[Title 21 CFR 892]
[Code of Federal Regulations (annual edition) - April 1, 1999 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION,]
[Subchapter H - MEDICAL DEVICES]
[Part 892 - RADIOLOGY DEVICES]
[From the U.S. Government Printing Office]
21FOOD AND DRUGS81999-04-011999-04-01falseRADIOLOGY DEVICES892PART 892FOOD AND DRUGSFOOD AND DRUG ADMINISTRATION,MEDICAL DEVICES
PART 892--RADIOLOGY DEVICES--Table of Contents
Subpart A--General Provisions
Sec.
892.1 Scope.
892.3 Effective dates of requirement for premarket approval.
892.9 Limitations of exemptions from section 510(k) of the Federal
Food, Drug, and Cosmetic Act (the act).
Subpart B--Diagnostic Devices
892.1000 Magnetic resonance diagnostic device.
892.1100 Scintillation (gamma) camera.
892.1110 Positron camera.
892.1130 Nuclear whole body counter.
892.1170 Bone densitometer.
892.1200 Emission computed tomography system.
892.1220 Fluorescent scanner.
892.1300 Nuclear rectilinear scanner.
892.1310 Nuclear tomography system.
892.1320 Nuclear uptake probe.
892.1330 Nuclear whole body scanner.
892.1350 Nuclear scanning bed.
892.1360 Radionuclide dose calibrator.
892.1370 Nuclear anthropomorphic phantom.
892.1380 Nuclear flood source phantom.
892.1390 Radionuclide rebreathing system.
892.1400 Nuclear sealed calibration source.
892.1410 Nuclear electrocardiograph synchronizer.
892.1420 Radionuclide test pattern phantom.
892.1540 Nonfetal ultrasonic monitor.
892.1550 Ultrasonic pulsed doppler imaging system.
892.1560 Ultrasonic pulsed echo imaging system.
892.1570 Diagnostic ultrasonic transducer.
892.1600 Angiographic x-ray system.
892.1610 Diagnostic x-ray beam-limiting device.
892.1620 Cine or spot fluorographic x-ray camera.
892.1630 Electrostatic x-ray imaging system.
892.1640 Radiographic film marking system.
892.1650 Image-intensified fluoroscopic x-ray system.
892.1660 Non-image-intensified fluoroscopic x-ray system.
892.1670 Spot-film device.
892.1680 Stationary x-ray system.
892.1700 Diagnostic x-ray high voltage generator.
892.1710 Mammographic x-ray system.
892.1720 Mobile x-ray system.
892.1730 Photofluorographic x-ray system.
892.1740 Tomographic x-ray system.
892.1750 Computed tomography x-ray system.
892.1760 Diagnostic x-ray tube housing assembly.
892.1770 Diagnostic x-ray tube mount.
892.1820 Pneumoencephalographic chair.
892.1830 Radiologic patient cradle.
892.1840 Radiographic film.
892.1850 Radiographic film cassette.
892.1860 Radiographic film/cassette changer.
892.1870 Radiographic film/cassette changer programmer.
892.1880 Wall-mounted radiographic cassette holder.
892.1890 Radiographic film illuminator.
892.1900 Automatic radiographic film processor.
892.1910 Radiographic grid.
892.1920 Radiographic head holder.
892.1940 Radiologic quality assurance instrument.
892.1950 Radiographic anthropomorphic phantom.
892.1960 Radiographic intensifying screen.
892.1970 Radiographic ECG/respirator synchronizer.
892.1980 Radiologic table.
892.1990 Transilluminator for breast evaluation.
892.2010 Medical image storage device.
892.2020 Medical image communications device.
892.2030 Medical image digitizer.
892.2040 Medical image hardcopy device.
892.2050 Picture archiving and communications system.
Subparts C-E [Reserved]
Subpart F--Therapeutic Devices
892.5050 Medical charged-particle radiation therapy system.
892.5300 Medical neutron radiation therapy system.
[[Page 478]]
892.5650 Manual radionuclide applicator system.
892.5700 Remote controlled radionuclide applicator system.
892.5710 Radiation therapy beam-shaping block.
892.5730 Radionuclide brachytherapy source.
892.5740 Radionuclide teletherapy source.
892.5750 Radionuclide radiation therapy system.
892.5770 Powered radiation therapy patient support assembly.
892.5780 Light beam patient position indicator.
892.5840 Radiation therapy simulation system.
892.5900 X-ray radiation therapy system.
892.5930 Therapeutic x-ray tube housing assembly.
Subpart G--Miscellaneous Devices
892.6500 Personnel protective shield.
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
Source: 53 FR 1567, Jan. 20, 1988, unless otherwise noted.
Subpart A--General Provisions
Sec. 892.1 Scope.
(a) This part sets forth the classification of radiology devices
intended for human use that are in commercial distribution.
(b) The identification of a device in a regulation in this part is
not a precise description of every device that is, or will be, subject
to the regulation. A manufacturer who submits a premarket notification
submission for a device under part 807 cannot show merely that the
device is accurately described by the section title and identification
provision of a regulation in this part but shall state why the device is
substantially equivalent to other devices, as required by Sec. 807.87.
(c) To avoid duplicative listings, a radiology device that has two
or more types of uses (e.g., use both as a diagnostic device and a
therapeutic device) is listed in one subpart only.
(d) References in this part to regulatory sections of the Code of
Federal Regulations are to chapter I of this title 21, unless otherwise
noted.
Sec. 892.3 Effective dates of requirement for premarket approval.
A device included in this part that is classified into class III
(premarket approval) shall not be commercially distributed after the
date shown in the regulation classifying the device unless the
manufacturer has an approval under section 515 of the act (unless an
exemption has been granted under section 520(g)(2) of the act). An
approval under section 515 of the act consists of FDA's issuance of an
order approving an application for premarket approval (PMA) for the
device or declaring completed a product development protocol (PDP) for
the device.
(a) Before FDA requires that a device commercially distributed
before the enactment date of the amendments, or a device that has been
found substantially equivalent to such a device, has an approval under
section 515 of the act, FDA must promulgate a regulation under section
515(b) of the act requiring such approval, except as provided in
paragraph (b) of this section. Such a regulation under section 515(b) of
the act shall not be effective during the grace period ending on the
90th day after its promulgation or on the last day of the 30th full
calendar month after the regulation that classifies the device into
class III is effective, whichever is later. See section 501(f)(2)(B) of
the act. Accordingly, unless an effective date of the requirement for
premarket approval is shown in the regulation for a device classified
into class III in this part, the device may be commercially distributed
without FDA's issuance of an order approving a PMA or declaring
completed a PDP for the device. If FDA promulgates a regulation under
section 515(b) of the act requiring premarket approval for a device,
section 501(f)(1)(A) of the act applies to the device.
(b) Any new, not substantially equivalent, device introduced into
commercial distribution on or after May 28, 1976, including a device
formerly marketed that has been substantially altered, is classified by
statute (section 513(f) of the act) into class III without any grace
period and FDA must have issued an order approving a PMA or declaring
completed a PDP for the device
[[Page 479]]
before the device is commercially distributed unless it is reclassified.
If FDA knows that a device being commerically distributed may be a
``new'' device as defined in this section because of any new intended
use or other reasons, FDA may codify the statutory classification of the
device into class III for such new use. Accordingly, the regulation for
such a class III device states that as of the enactment date of the
amendments, May 28, 1976, the device must have an approval under section
515 of the act before commercial distribution.
Sec. 892.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
(a) The Food and Drug Administration's (FDA's) decision to grant an
exemption from the requirement of premarket notification (section 510(k)
of the act) for a generic type of class I device is based upon the
existing and reasonably foreseeable characteristics of commercially
distributed devices within that generic type. Because FDA cannot
anticipate every change in intended use or characteristic that could
significantly affect a device's safety or effectiveness, manufacturers
of any commercially distributed class I device for which FDA has granted
an exemption from the requirement of premarket notification must still
submit a premarket notification to FDA before introducing or delivering
for introduction into interstate commerce for commercial distribution
the device when:
(1) The device is intended for a use different from its intended use
before May 28, 1976, or the device is intended for a use different from
the intended use of a preamendments device to which it had been
determined to be substantially equivalent; e.g., the device is intended
for a different medical purpose, or the device is intended for lay use
where the former intended use was by health care professionals only; or
(2) The modified device operates using a different fundamental
scientific technology than that in use in the device before May 28,
1976; e.g., a surgical instrument cuts tissue with a laser beam rather
than with a sharpened metal blade, or an in vitro diagnostic device
detects or identifies infectious agents by using a deoxyribonucleic acid
(DNA) probe or nucleic acid hybridization technology rather than culture
or immunoassay technology.
(b) The exemption from the requirement of premarket notification for
a generic type of class II device applies only to those class II devices
that have existing or reasonably foreseeable characteristics of
commercially distributed devices within that generic type, or, in the
case of in vitro diagnostic devices, for which a misdiagnosis, as a
result of using the device, would not be associated with high morbidity
or mortality. A class II device for which FDA has granted an exemption
from the requirement of premarket notification must still submit a
premarket notification when:
(1) The device is intended for a use different from the intended use
of a legally marketed device in that generic type of device; e.g., the
device is intended for a different medical purpose, or the device is
intended for lay use where the former intended use was by health care
professionals only; or
(2) The modified device operates using a different fundamental
scientific technology than a legally marketed device in that generic
type of device; e.g., a surgical instrument cuts tissue with a laser
beam rather than with a sharpened metal blade, or an in vitro diagnostic
device detects or identifies infectious agents by using deoxyribonucleic
acid (DNA) probe or nucleic acid hybridization technology rather than
culture or immunoassay technology; or
(3) The device is an in vitro device that is intended:
(i) For use in the diagnosis, monitoring, or screening of neoplastic
diseases with the exception of immunohistochemical devices;
(ii) For use in screening or diagnosis of familial and acquired
genetic disorders, including inborn errors of metabolism;
(iii) For measuring an analyte that serves as a surrogate marker for
screening, diagnosis, or monitoring life-threatening diseases such as
acquired immune deficiency syndrome
[[Page 480]]
(AIDS), chronic or active hepatitis, tuberculosis, or myocardial
infarction or to monitor therapy;
(iv) For assessing the risk of cardiovascular diseases;
(v) For use in diabetes management;
(vi) For identifying or inferring the identity of a microorganism
directly from clinical material;
(vii) For detection of antibodies to microorganisms other than
immunoglobulin G (IgG) and IgG assays when the results are not
qualitative, or are used to determine immunity, or the assay is intended
for use in matrices other than serum or plasma;
(viii) For noninvasive testing; and
(ix) For near patient testing (point of care).
[54 FR 13831, Apr. 5, 1989, as amended at 63 FR 59231, Nov. 3, 1998]
Subpart B--Diagnostic Devices
Sec. 892.1000 Magnetic resonance diagnostic device.
(a) Identification. A magnetic resonance diagnostic device is
intended for general diagnostic use to present images which reflect the
spatial distribution and/or magnetic resonance spectra which reflect
frequency and distribution of nuclei exhibiting nuclear magnetic
resonance. Other physical parameters derived from the images and/or
spectra may also be produced. The device includes hydrogen-1 (proton)
imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31
spectroscopy, and chemical shift imaging (preserving simultaneous
frequency and spatial information).
(b) Classification. Class II.
[53 FR 5078, Feb. 1, 1989]
Sec. 892.1100 Scintillation (gamma) camera.
(a) Identification. A scintillation (gamma) camera is a device
intended to image the distribution of radionuclides in the body by means
of a photon radiation detector. This generic type of device may include
signal analysis and display equipment, patient and equipment supports,
radionuclide anatomical markers, component parts, and accessories.
(b) Classification. Class I.
[55 FR 48443, Nov. 20, 1990]
Sec. 892.1110 Positron camera.
(a) Identification. A positron camera is a device intended to image
the distribution of positron-emitting radionuclides in the body. This
generic type of device may include signal analysis and display
equipment, patient and equipment supports, radionuclide anatomical
markers, component parts, and accessories.
(b) Classification. Class I.
[55 FR 48444, Nov. 20, 1990]
Sec. 892.1130 Nuclear whole body counter.
(a) Identification. A nuclear whole body counter is a device
intended to measure the amount of radionuclides in the entire body. This
generic type of device may include signal analysis and display
equipment, patient and equipment supports, component parts, and
accessories.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[53 FR 1567, Jan. 20, 1988, as amended at 59 FR 63015, Dec. 7, 1994]
[55 FR 48444, Nov. 20, 1990]
Sec. 892.1170 Bone densitometer.
(a) Identification. A bone densitometer is a device intended for
medical purposes to measure bone density and mineral content by x-ray or
gamma ray transmission measurements through the bone and adjacent
tissues. This generic type of device may include signal analysis and
display equipment, patient and equipment supports, component parts, and
accessories.
(b) Classification. Class II.
Sec. 892.1200 Emission computed tomography system.
(a) Identification. An emission computed tomography system is a
device intended to detect the location and distribution of gamma ray-
and positron-emitting radionuclides in the body and produce cross-
sectional images through computer reconstruction of the data.
[[Page 481]]
This generic type of device may include signal analysis and display
equipment, patient and equipment supports, radionuclide anatomical
markers, component parts, and accessories.
(b) Classification. Class II.
Sec. 892.1220 Fluorescent scanner.
(a) Identification. A fluorescent scanner is a device intended to
measure the induced fluorescent radiation in the body by exposing the
body to certain x-rays or low-energy gamma rays. This generic type of
device may include signal analysis and display equipment, patient and
equipment supports, component parts and accessories.
(b) Classification. Class II.
Sec. 892.1300 Nuclear rectilinear scanner.
(a) Identification. A nuclear rectilinear scanner is a device
intended to image the distribution of radionuclides in the body by means
of a detector (or detectors) whose position moves in two directions with
respect to the patient. This generic type of device may include signal
analysis and display equipment, patient and equipment supports,
radionuclide anatomical markers, component parts, and accessories.
(b) Classification. Class I.
[55 FR 48444, Nov. 20, 1990]
Sec. 892.1310 Nuclear tomography system.
(a) Identification. A nuclear tomography system is a device intended
to detect nuclear radiation in the body and produce images of a specific
cross-sectional plane of the body by blurring or eliminating detail from
other planes. This generic type of devices may include signal analysis
and display equipment, patient and equipment supports, radionuclide
anatomical markers, component parts, and accessories.
(b) Classification. Class II.
Sec. 892.1320 Nuclear uptake probe.
(a) Identification. A nuclear uptake probe is a device intended to
measure the amount of radionuclide taken up by a particular organ or
body region. This generic type of device may include a single or
multiple detector probe, signal analysis and display equipment, patient
and equipment supports, component parts, and accessories.
(b) Classification. Class I.
[55 FR 48444, Nov. 20, 1990]
Sec. 892.1330 Nuclear whole body scanner.
(a) Identification. A nuclear whole body scanner is a device
intended to measure and image the distribution of radionuclides in the
body by means of a wide-aperture detector whose position moves in one
direction with respect to the patient. This generic type of device may
include signal analysis and display equipment, patient and equipment
supports, radionuclide anatomical markers, component parts, and
accessories.
(b) Classification. Class I.
[55 FR 48444, Nov. 20, 1990]
Sec. 892.1350 Nuclear scanning bed.
(a) Identification. A nuclear scanning bed is an adjustable bed
intended to support a patient during a nuclear medicine procedure.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter only
when the device is labeled with weight limit, is used with planar
scanning only, and is not for diagnostic X-ray use.
[55 FR 48444, Nov. 20, 1990, as amended at 59 FR 63015, Dec. 7, 1994]
Sec. 892.1360 Radionuclide dose calibrator.
(a) Identification. A radionuclide dose calibrator is a radiation
detection device intended to assay radionuclides before their
administration to patients.
(b) Classification. Class II.
Sec. 892.1370 Nuclear anthropomorphic phantom.
(a) Identification. A nuclear anthropomorphic phantom is a human
tissue facsimile that contains a radioactive source or a cavity in which
a radioactive sample can be inserted. It is intended to calibrate
nuclear uptake probes or other medical instruments.
[[Page 482]]
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989]
Sec. 892.1380 Nuclear flood source phantom.
(a) Identification. A nuclear flood source phantom is a device that
consists of a radiolucent container filled with a uniformly distributed
solution of a desired radionuclide. It is intended to calibrate a
medical gamma camera-collimator system for uniformity of response.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989]
Sec. 892.1390 Radionuclide rebreathing system.
(a) Identification. A radionuclide rebreathing system is a device
intended to be used to contain a gaseous or volatile radionuclide or a
radionuclide-labeled aerosol and permit it to be respired by the patient
during nuclear medicine ventilatory tests (testing process of exchange
between the lungs and the atmosphere). This generic type of device may
include signal analysis and display equipment, patient and equipment
supports, component parts, and accessories.
(b) Classification. Class II.
Sec. 892.1400 Nuclear sealed calibration source.
(a) Identification. A nuclear sealed calibration source is a device
that consists of an encapsulated reference radionuclide intended for
calibration of medical nuclear radiation detectors.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989]
Sec. 892.1410 Nuclear electrocardiograph synchronizer.
(a) Identification. A nuclear electrocardiograph synchronizer is a
device intended for use in nuclear radiology to relate the time of image
formation to the cardiac cycle during the production of dynamic cardiac
images.
(b) Classification. Class I.
[55 FR 48444, Nov. 20, 1990]
Sec. 892.1420 Radionuclide test pattern phantom.
(a) Identification. A radionuclide test pattern phantom is a device
that consists of an arrangement of radiopaque or radioactive material
sealed in a solid pattern intended to serve as a test for a performance
characteristic of a nuclear medicine imaging device.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989]
Sec. 892.1540 Nonfetal ultrasonic monitor.
(a) Identification. A nonfetal ultrasonic monitor is a device that
projects a continuous high-frequency sound wave into body tissue other
than a fetus to determine frequency changes (doppler shift) in the
reflected wave and is intended for use in the investigation of nonfetal
blood flow and other nonfetal body tissues in motion. This generic type
of device may include signal analysis and display equipment, patient and
equipment supports, component parts, and accessories.
(b) Classification. Class II.
Sec. 892.1550 Ultrasonic pulsed doppler imaging system.
(a) Identification. An ultrasonic pulsed doppler imaging system is a
device that combines the features of continuous wave doppler-effect
technology with pulsed-echo effect technology and is intended to
determine stationary body tissue characteristics, such as depth or
location of tissue interfaces or dynamic tissue characteristics such as
velocity of blood or tissue motion. This
[[Page 483]]
generic type of device may include signal analysis and display
equipment, patient and equipment supports, component parts, and
accessories.
(b) Classification. Class II.
Sec. 892.1560 Ultrasonic pulsed echo imaging system.
(a) Identification. An ultrasonic pulsed echo imaging system is a
device intended to project a pulsed sound beam into body tissue to
determine the depth or location of the tissue interfaces and to measure
the duration of an acoustic pulse from the transmitter to the tissue
interface and back to the receiver. This generic type of device may
include signal analysis and display equipment, patient and equipment
supports, component parts, and accessories.
(b) Classification. Class II.
Sec. 892.1570 Diagnostic ultrasonic transducer.
(a) Identification. A diagnostic ultrasonic transducer is a device
made of a piezoelectric material that converts electrical signals into
acoustic signals and acoustic signals into electrical signals and
intended for use in diagnostic ultrasonic medical devices. Accessories
of this generic type of device may include transmission media for
acoustically coupling the transducer to the body surface, such as
acoustic gel, paste, or a flexible fluid container.
(b) Classification. Class II.
Sec. 892.1600 Angiographic x-ray system.
(a) Identification. An angiographic x-ray system is a device
intended for radiologic visualization of the heart, blood vessels, or
lymphatic system during or after injection of a contrast medium. This
generic type of device may include signal analysis and display
equipment, patient and equipment supports, component parts, and
accessories.
(b) Classification. Class II.
Sec. 892.1610 Diagnostic x-ray beam-limiting device.
(a) Identification. A diagnostic x-ray beam-limiting device is a
device such as a collimator, a cone, or an aperture intended to restrict
the dimensions of a diagnostic x-ray field by limiting the size of the
primary x-ray beam.
(b) Classification. Class II.
Sec. 892.1620 Cine or spot fluorographic x-ray camera.
(a) Identification. A cine or spot fluorographic x-ray camera is a
device intended to photograph diagnostic images produced by x-rays with
an image intensifier.
(b) Classification. Class II.
Sec. 892.1630 Electrostatic x-ray imaging system.
(a) Identification. An electrostatic x-ray imaging system is a
device intended for medical purposes that uses an electrostatic field
across a semiconductive plate, a gas-filled chamber, or other similar
device to convert a pattern of x-radiation into an electrostatic image
and, subsequently, into a visible image. This generic type of device may
include signal analysis and display equipment, patient and equipment
supports, component parts, and accessories.
(b) Classification. Class II.
Sec. 892.1640 Radiographic film marking system.
(a) Identification. A radiographic film marking system is a device
intended for medical purposes to add identification and other
information onto radiographic film by means of exposure to visible
light.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48444, Nov. 20, 1990, as amended at 59 FR 63015, Dec. 7, 1994]
Sec. 892.1650 Image-intensified fluoroscopic x-ray system.
(a) Identification. An image-intensified fluoroscopic x-ray system
is a device intended to visualize anatomical structures by converting a
pattern of x-radiation into a visible image through electronic
amplification. This generic type of device may include signal analysis
and display equipment, patient and equipment supports, component parts,
and accessories.
(b) Classification. Class II.
[[Page 484]]
Sec. 892.1660 Non-image-intensified fluoroscopic x-ray system.
(a) Identification. A non-image-intensified fluoroscopic x-ray
system is a device intended to be used to visualize anatomical
structures by using a fluorescent screen to convert a pattern of x-
radiation into a visible image. This generic type of device may include
signal analysis and display equipment, patient and equipment supports,
component parts, and accessories.
(b) Classification. Class II.
Sec. 892.1670 Spot-film device.
(a) Identification. A spot-film device is an electromechanical
component of a fluoroscopic x-ray system that is intended to be used for
medical purposes to position a radiographic film cassette to obtain
radiographs during fluoroscopy.
(b) Classification. Class II.
Sec. 892.1680 Stationary x-ray system.
(a) Identification. A stationary x-ray system is a permanently
installed diagnostic system intended to generate and control x-rays for
examination of various anatomical regions. This generic type of device
may include signal analysis and display equipment, patient and equipment
supports, component parts, and accessories.
(b) Classification. Class II.
Sec. 892.1700 Diagnostic x-ray high voltage generator.
(a) Identification. A diagnostic x-ray high voltage generator is a
device that is intended to supply and control the electrical energy
applied to a diagnostic x-ray tube for medical purposes. This generic
type of device may include a converter that changes alternating current
to direct current, filament transformers for the x-ray tube, high
voltage switches, electrical protective devices, or other appropriate
elements.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996]
Sec. 892.1710 Mammographic x-ray system.
(a) Identification. A mammographic x-ray system is a device intended
to be used to produce radiographs of the breast. This generic type of
device may include signal analysis and display equipment, patient and
equipment supports, component parts, and accessories.
(b) Classification. Class II.
Sec. 892.1720 Mobile x-ray system.
(a) Identification. A mobile x-ray system is a transportable device
system intended to be used to generate and control x-ray for diagnostic
procedures. This generic type of device may include signal analysis and
display equipment, patient and equipment supports, component parts, and
accessories.
(b) Classification. Class II.
Sec. 892.1730 Photofluorographic x-ray system.
(a) Identification. A photofluorographic x-ray system is a device
that includes a fluoroscopic x-ray unit and a camera intended to be used
to produce, then photograph, a fluoroscopic image of the body. This
generic type of device may include signal analysis and display
equipment, patient and equipment supports, component parts, and
accessories.
(b) Classification. Class II.
Sec. 892.1740 Tomographic x-ray system.
(a) Identification. A tomographic x-ray system is an x-ray device
intended to be used to produce radiologic images of a specific cross-
sectional plane of the body by blurring or eliminating detail from other
planes. This generic type of device may include signal analysis and
display equipment, patient and equipment supports, component parts, and
accessories.
(b) Classification. Class II.
Sec. 892.1750 Computed tomography x-ray system.
(a) Identification. A computed tomography x-ray system is a
diagnostic x-ray system intended to produce cross-sectional images of
the body by computer reconstruction of x-ray transmission data from the
same axial plane taken at different angles. This generic
[[Page 485]]
type of device may include signal analysis and display equipment,
patient and equipment supports, component parts, and accessories.
(b) Classification. Class II.
Sec. 892.1760 Diagnostic x-ray tube housing assembly.
(a) Identification. A diagnostic x-ray tube housing assembly is an
x-ray generating tube encased in a radiation-shielded housing that is
intended for diagnostic purposes. This generic type of device may
include high voltage and filament transformers or other appropriate
components.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996]
Sec. 892.1770 Diagnostic x-ray tube mount.
(a) Identification. A diagnostic x-ray tube mount is a device
intended to support and to position the diagnostic x-ray tube housing
assembly for a medical radiographic procedure.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996]
Sec. 892.1820 Pneumoencephalographic chair.
(a) Identification. A pneumoencephalographic chair is a chair
intended to support and position a patient during pneumoencephalography
(x-ray imaging of the brain).
(b) Classification. Class II.
Sec. 892.1830 Radiologic patient cradle.
(a) Identification. A radiologic patient cradle is a support device
intended to be used for rotational positioning about the longitudinal
axis of a patient during radiologic procedures.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996]
Sec. 892.1840 Radiographic film.
(a) Identification. Radiographic film is a device that consists of a
thin sheet of radiotransparent material coated on one or both sides with
a photographic emulsion intended to record images during diagnostic
radiologic procedures.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807.
Sec. 892.1850 Radiographic film cassette.
(a) Identification. A radiographic film cassette is a device
intended for use during diagnostic x-ray procedures to hold a
radiographic film in close contact with an x-ray intensifying screen and
to provide a light-proof enclosure for direct exposure of radiographic
film.
(b) Classification. Class II.
Sec. 892.1860 Radiographic film/cassette changer.
(a) Identification. A radiographic film/cassette changer is a device
intended to be used during a radiologic procedure to move a radiographic
film or cassette between x-ray exposures and to position it during the
exposure.
(b) Classification. Class II.
Sec. 892.1870 Radiographic film/cassette changer programmer.
(a) Identification. A radiographic film/cassette changer programmer
is a device intended to be used to control the operations of a film or
cassette changer during serial medical radiography.
(b) Classification. Class II.
Sec. 892.1880 Wall-mounted radiographic cassette holder.
(a) Identification. A wall-mounted radiographic cassette holder is a
device that is a support intended to hold and position radiographic
cassettes for a radiographic exposure for medical use.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996]
[[Page 486]]
Sec. 892.1890 Radiographic film illuminator.
(a) Identification. A radiographic film illuminator is a device
containing a visible light source covered with a translucent front that
is intended to be used to view medical radiographs.
(b) Classification. Class I.
[55 FR 48444, Nov. 20, 1990]
Sec. 892.1900 Automatic radiographic film processor.
(a) Identification. An automatic radiographic film processor is a
device intended to be used to develop, fix, wash, and dry automatically
and continuously film exposed for medical purposes.
(b) Classification. Class II.
[55 FR 48444, Nov. 20, 1990]
Sec. 892.1910 Radiographic grid.
(a) Identification. A radiographic grid is a device that consists of
alternating radiolucent and radiopaque strips intended to be placed
between the patient and the image receptor to reduce the amount of
scattered radiation reaching the image receptor.
(b) Classification. Class I.
Sec. 892.1920 Radiographic head holder.
(a) Identification. A radiographic head holder is a device intended
to position the patient's head during a radiographic procedure.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807. The device is exempt
from the current good manufacturing practice regulations in part 820,
with the exception of Sec. 820.180, with respect to general requirements
concerning records, and Sec. 820.198, with respect to complaint files.
Sec. 892.1940 Radiologic quality assurance instrument.
(a) Identification. A radiologic quality assurance instrument is a
device intended for medical purposes to measure a physical
characteristic associated with another radiologic device.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807. The device is exempt
from the current good manufacturing practice regulations in part 820,
with the exception of Sec. 820.180, with respect to general requirements
concerning records, and Sec. 820.198, with respect to complaint files.
Sec. 892.1950 Radiographic anthropomorphic phantom.
(a) Identification. A radiographic anthropomorphic phantom is a
device intended for medical purposes to simulate a human body for
positioning radiographic equipment.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807. The device is exempt
from the current good manufacturing practice regulations in part 820,
with the exception of Sec. 820.180, with respect to general requirements
concerning records, and Sec. 820.198, with respect to complaint files.
Sec. 892.1960 Radiographic intensifying screen.
(a) Identification. A radiographic intensifying screen is a device
that is a thin radiolucent sheet coated with a luminescent material that
transforms incident x-ray photons into visible light and intended for
medical purposes to expose radiographic film.
(b) Classification. Class I.
Sec. 892.1970 Radiographic ECG/respirator synchronizer.
(a) Identification. A radiographic ECG/respirator synchronizer is a
device intended to be used to coordinate an x-ray film exposure with
the signal from an electrocardiograph (ECG) or respirator at a
predetermined phase of the cardiac or respiratory cycle.
(b) Classification. Class I.
[55 FR 48444, Nov. 20, 1990]
Sec. 892.1980 Radiologic table.
(a) Identification. A radiologic table is a device intended for
medical purposes to support a patient during radiologic procedures. The
table may be fixed or tilting and may be electrically powered.
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures
[[Page 487]]
in subpart E of part 807 of this chapter subject to Sec. 892.9.
[53 FR 1567, Jan. 20, 1988, as amended at 63 FR 59231, Nov. 3, 1998]
Sec. 892.1990 Transilluminator for breast evaluation.
(a) Identification. A transilluminator, also known as a
diaphanoscope or lightscanner, is an electrically powered device that
uses low intensity emissions of visible light and near-infrared
radiation (approximately 700-1050 nanometers (nm)), transmitted through
the breast, to visualize translucent tissue for the diagnosis of cancer,
other conditions, diseases, or abnormalities.
(b) Classification. Class III (premarket approval).
(c) Date premarket approval (PMA) or notice of completion of a
product development protocol (PDP) is required. The effective date of
the requirement for premarket approval has not been established. See
Sec. 892.3.
[60 FR 36639, July 18, 1995]
Sec. 892.2010 Medical image storage device.
(a) Identification. A medical image storage device is a device that
provides electronic storage and retrieval functions for medical images.
Examples include devices employing magnetic and optical discs, magnetic
tape, and digital memory.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter only
when the device stores images without performing irreversible data
compression.
[63 FR 23387, Apr. 29, 1998; 63 FR 44998, Aug. 24, 1998]
Sec. 892.2020 Medical image communications device.
(a) Identification. A medical image communications device provides
electronic transfer of medical image data between medical devices. It
may include a physical communications medium, modems, interfaces, and a
communications protocol.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter only
when the device transfers images without performing irreversible data
compression.
[63 FR 23387, Apr. 29, 1998; 63 FR 44998, Aug. 24, 1998]
Sec. 892.2030 Medical image digitizer.
(a) Identification. A medical image digitizer is a device intended
to convert an analog medical image into a digital format. Examples
include Iystems employing video frame grabbers, and scanners which use
lasers or charge-coupled devices.
(b) Classification. Class II (special controls; voluntary
standards--Digital Imaging and Communications in Medicine (DICOM) Std.,
Joint Photographic Experts Group (JPEG) Std.).
[63 FR 23387, Apr. 29, 1998]
Sec. 892.2040 Medical image hardcopy device.
(a) Identification. A medical image hardcopy device is a device that
produces a visible printed record of a medical image and associated
identification information. Examples include multiformat cameras and
laser printers.
(b) Classification. Class II (special controls; voluntary
standards--Digital Imaging and Communications in Medicine (DICOM) Std.,
Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture
and Television Engineers (SMPTE) Test Pattern).
[63 FR 23387, Apr. 29, 1998]
Sec. 892.2050 Picture archiving and communications system.
(a) Identification. A picture archiving and communications system is
a device that provides one or more capabilities relating to the
acceptance, transfer, display, storage, and digital processing of
medical images. Its hardware components may include workstations,
digitizers, communications devices, computers, video monitors, magnetic,
optical disk, or other digital data storage devices, and hardcopy
devices. The software components may provide functions for performing
operations related to image manipulation, enhancement, compression or
quantification.
(b) Classification. Class II (special controls; voluntary
standards--Digital
[[Page 488]]
Imaging and Communications in Medicine (DICOM) Std., Joint Photographic
Experts Group (JPEG) Std., Society of Motion Picture and Television
Engineers (SMPTE) Test Pattern).
[63 FR 23387, Apr. 29, 1998]
Subparts C-E [Reserved]
Subpart F--Therapeutic Devices
Sec. 892.5050 Medical charged-particle radiation therapy system.
(a) Identification. A medical charged-particle radiation therapy
system is a device that produces by acceleration high energy charged
particles (e.g., electrons and protons) intended for use in radiation
therapy. This generic type of device may include signal analysis and
display equipment, patient and equipment supports, treatment planning
computer programs, component parts, and accessories.
(b) Classification. Class II. When intended for use as a quality
control system, the film dosimetry system (film scanning system)
included as an accessory to the device described in paragraph (a) of
this section, is exempt from the premarket notification procedures in
subpart E of part 807 of this chapter subject to the limitations in
Sec. 892.9.
[53 FR 1567, Jan. 20, 1988, as amended at 64 FR 1125, Jan. 8, 1999]
Sec. 892.5300 Medical neutron radiation therapy system.
(a) Identification. A medical neutron radiation therapy system is a
device intended to generate high-energy neutrons for radiation therapy.
This generic type of device may include signal analysis and display
equipment, patient and equipment support, treatment planning computer
programs, component parts, and accessories.
(b) Classification. Class II.
Sec. 892.5650 Manual radionuclide applicator system.
(a) Identification. A manual radionuclide applicator system is a
manually operated device intended to apply a radionuclide source into
the body or to the surface of the body for radiation therapy. This
generic type of device may include patient and equipment supports,
component parts, treatment planning computer programs, and accessories.
(b) Classification. Class I.
Sec. 892.5700 Remote controlled radionuclide applicator system.
(a) Identification. A remote controlled radionuclide applicator
system is an electromechanical or pneumatic device intended to enable an
operator to apply, by remote control, a radionuclide source into the
body or to the surface of the body for radiation therapy. This generic
type of device may include patient and equipment supports, component
parts, treatment planning computer programs, and accessories.
(b) Classification. Class II.
Sec. 892.5710 Radiation therapy beam-shaping block.
(a) Identification. A radiation therapy beam-shaping block is a
device made of a highly attenuating material (such as lead) intended for
medical purposes to modify the shape of a beam from a radiation therapy
source.
(b) Classification. Class II.
Sec. 892.5730 Radionuclide brachytherapy source.
(a) Identification. A radionuclide brachytherapy source is a device
that consists of a radionuclide which may be enclosed in a sealed
container made of gold, titanium, stainless steel, or platinum and
intended for medical purposes to be placed onto a body surface or into a
body cavity or tissue as a source of nuclear radiation for therapy.
(b) Classification. Class II.
Sec. 892.5740 Radionuclide teletherapy source.
(a) Identification. A radionuclide teletherapy source is a device
consisting of a radionuclide enclosed in a sealed container. The device
is intended for radiation therapy, with the radiation source located at
a distance from the patient's body.
[[Page 489]]
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[53 FR 1567, Jan. 20, 1988, as amended at 59 FR 63015, Dec. 7, 1994]
Sec. 892.5750 Radionuclide radiation therapy system.
(a) Identification. A radionuclide radiation therapy system is a
device intended to permit an operator to administer gamma radiation
therapy, with the radiation source located at a distance from the
patient's body. This generic type of device may include signal analysis
and display equipment, patient and equipment supports, treatment
planning computer programs, component parts (including beam-limiting
devices), and accessories.
(b) Classification. Class II.
Sec. 892.5770 Powered radiation therapy patient support assembly.
(a) Identification. A powered radiation therapy patient support
assembly is an electrically powered adjustable couch intended to support
a patient during radiation therapy.
(b) Classification. Class II.
Sec. 892.5780 Light beam patient position indicator.
(a) Identification. A light beam patient position indicator is a
device that projects a beam of light (incoherent light or laser) to
determine the alignment of the patient with a radiation beam. The beam
of light is intended to be used during radiologic procedures to ensure
proper positioning of the patient and to monitor alignment of the
radiation beam with the patient's anatomy.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996]
Sec. 892.5840 Radiation therapy simulation system.
(a) Identification. A radiation therapy simulation system is a
fluoroscopic or radiographic x-ray system intended for use in localizing
the volume to be exposed during radiation therapy and confirming the
position and size of the therapeutic irradiation field produced. This
generic type of device may include signal analysis and display
equipment, patient and equipment supports, treatment planning computer
programs, component parts, and accessories.
(b) Classification. Class II.
Sec. 892.5900 X-ray radiation therapy system.
(a) Identification. An x-ray radiation therapy system is a device
intended to produce and control x-rays used for radiation therapy. This
generic type of device may include signal analysis and display
equipment, patient and equipment supports, treatment planning computer
programs, component parts, and accessories.
(b) Classification. Class II.
Sec. 892.5930 Therapeutic x-ray tube housing assembly.
(a) Identification. A therapeutic x-ray tube housing assembly is an
x-ray generating tube encased in a radiation-shielded housing intended
for use in radiation therapy. This generic type of device may include
high-voltage and filament transformers or other appropriate components
when contained in radiation-shielded housing.
(b) Classification. Class II.
Subpart G--Miscellaneous Devices
Sec. 892.6500 Personnel protective shield.
(a) Identification. A personnel protective shield is a device
intended for medical purposes to protect the patient, the operator, or
other persons from unnecessary exposure to radiation during radiologic
procedures by providing an attenuating barrier to radiation. This
generic type of device may include articles of clothing, furniture, and
movable or stationary structures.
(b) Classification. Class I. If the device's labeling specifies the
lead equivalence, it is exempt from the premarket notification
procedures in subpart E of part 807 of this chapter.
[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996]
[[Page 490]]