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U.S. Department of Health and Human Services

List of Devices for Third Party Review

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Database updated: February 7, 2002

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This page lists devices currently eligible for third-party review under the FDA's Accredited Persons Program. Premarket notifications ["510(k)'s"] for devices on this list can be submitted to FDA-accredited third parties (Accredited Persons) in lieu of FDA. Information on the Accredited Persons Program, including links to this page and to a list of Accredited Persons, is available at the Accredited Persons Inspection Program website.

The following topics are discussed in this introduction to the list of eligible devices:

  • How to use the list of eligible devices
  • Some important exceptions to the list
  • Expansion pilot

How to Use the List of Eligible Devices

The list has five columns:

  • The first column provides the classification regulation number for each device from Title 21, Code of Federal Regulations (CFR), Parts 862-892. A classification regulation identifies a generic type of device and specifies the regulatory class that FDA has assigned to the device.
  • The second and third columns show the classification name for the device from the CFR, and the class of the device, respectively. In the second column, under each classification regulation name, one or more 3-letter product codes appear, along with the device name associated with each product code. Product codes represent specific subsets of devices grouped under the same classification regulation name. Manufacturers should determine the classification of their device at the product code level that most appropriately identifies their device(s).
  • The fourth column indicates if a device (product code) is included in the expansion pilot, described below, by showing the word "pilot." If this column is blank, the device is eligible for review under the pre-existing program and is not part of the expansion pilot.
  • The fifth column provides a link to device-specific guidance, if available, or to general guidance to assist manufacturers in the preparation-and Accredited Persons in the review-of 510(k)'s for eligible devices. Links are not provided for devices in the expansion pilot; device-specific guidance does not exist for these devices, and special procedures apply to the review of 510(k)'s for these devices by Accredited Persons, as discussed in FDA's January 2001 procedural guidance for the Accredited Persons Program, cited below.
Some Important Exceptions to the List

There are some exceptions that are not reflected in the eligible device list:

  • A device may be eligible even if it does not appear on the list if it is a Class I or Class II device that has been exempted from 510(k) by regulation, but requires a 510(k) because it exceeds the limitations of the exemption (as discussed in FDA's device classification regulations). Devices that are exempt from 510(k) are not shown on the list.
  • A Class II device on the list is ineligible if a 510(k) for the device requires clinical data to demonstrate substantial equivalence. This exception is discussed in FDA's procedural guidance for the Accredited Persons Program, cited below.
  • A device on the list is ineligible if a 510(k) for the device requires multi-Center review (e.g., 510(k)'s for drug/device combination products) or if a Center other than CDRH (e.g., the Center for Biologics Evaluation and Research) has primary responsibility for review.
Expansion Pilot

In an effort to encourage greater use of the Accredited Persons Program, FDA expanded the third party pilot to permit Accredited Persons to review many Class II devices that were not previously eligible. The expanded pilot allows, subject to certain conditions, Accredited Persons to review Class II devices for which there are no device-specific guidance documents. Information on the expansion pilot, including criteria allowing for the review of these Class II devices, can be found in the guidance document entitled Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties. Accredited Persons and other interested parties should refer to Section II.B., Purpose and Nature of the Program, for the criteria that would allow for the review of the Class II devices in the expansion pilot.


Radiology

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Section No. Regulation Name
Product Code-Device Name
Class Pilot
Relevant
Guidance/Standard
892.1000 MAGNETIC RESONANCE DIAGNOSTIC DEVICE II  
  LNH -  System, Nuclear Magnetic Resonance Imaging      
  LNI -  System, Nuclear Magnetic Resonance Spectroscopic      
  MOS -  Coil, Magnetic Resonance, Specialty      
892.1100 SCINTILLATION GAMMA CAMERA I  
 General Guidance
  IYX -  Camera, Scintillation (Gamma)      
892.1110 POSITRON CAMERA I  
 General Guidance
  IZC -  Camera, Positron      
892.1170 BONE DENSITOMETER II  
  KGI -  Densitometer, Bone   Pilot  
892.1200 EMISSION COMPUTED TOMOGRAPHY SYSTEM II  
  KPS -  System, Tomography, Computed, Emission      
892.1220 FLUORESCENT SCANNER II  
  JAO -  Scanner, Fluorescent   Pilot  
892.1310 NUCLEAR TOMOGRAPHIC SYSTEM II  
  JWM -  System, Tomographic, Nuclear      
892.1360 RADIONUCLIDE DOSE CALIBRATOR II  
  KPT -  Calibrator, Dose, Radionuclide      
892.1390 RADIONUCLIDE REBREATHING SYSTEM II  
  IYT -  System, Rebreathing, Radionuclide   Pilot  
892.1540 NONFETAL ULTRASONIC MONITOR II  
  JAF -  Monitor, Ultrasonic, Nonfetal      
892.1550 ULTRASONIC PULSED DOPPLER IMAGING SYSTEM II  
  IYN -  System, Imaging, Pulsed Doppler, Ultrasonic      
892.1560 ULTRASONIC PULSED ECHO IMAGING SYSTEM II  
  IYO -  System, Imaging, Pulsed Echo, Ultrasonic      
892.1570 DIAGNOSTIC ULTRASONIC TRANSDUCER II  
  ITX -  Transducer, Ultrasonic, Diagnostic      
  MUI -  Media,Coupling,Ultrasound      
892.1600 ANGIOGRAPHIC X-RAY SYSTEM II  
 
  IZI -  System, X-Ray, Angiographic      
892.1610 DIAGNOSTIC X-RAY BEAM LIMITING DEVICE II  
 
  IZS -  Aperture, Radiographic      
  IZT -  Cone, Radiographic      
  IZW -  Collimator, Automatic, Radiographic      
  IZX -  Collimator, Manual, Radiographic      
  KPW -  Device, Beam Limiting, X-Ray, Diagnostic   Pilot  
892.1620 CINE OR SPOT FLUOROGRAPHIC X-RAY CAMERA II  
 
  IZJ -  Camera, X-Ray, Fluorographic, Cine Or Spot      
892.1630 ELECTROSTATIC X-RAY IMAGING SYSTEM II  
 
  IXK -  System, Imaging, X-Ray, Electrostatic      
892.1650 IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM II  
  JAA -  System, X-Ray, Fluoroscopic, Image-Intensified      
892.1660 NON-IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM II  
  JAB -  System, X-Ray, Fluoroscopic, Non-Image-Intensified   Pilot  
892.1670 SPOT FILM DEVICE II  
 
  IXL -  Device, Spot-Film      
892.1680 STATIONARY X-RAY SYSTEM II  
 
  KPR -  System, X-Ray, Stationary      
  MQB -  Solid State X-Ray Imager (Flat Panel/Digital Imager)      
  MWP -  Cabinet,X-Ray System   Pilot  
  OIO -  Radiographic Contrast Tray      
892.1710 MAMMOGRAPHIC X-RAY SYSTEM II  
 
  IZH -  System, X-Ray, Mammographic      
892.1720 MOBILE X-RAY SYSTEM II  
 
  IZL -  System, X-Ray, Mobile      
892.1730 PHOTOFLUOROGRAPHIC X-RAY SYSTEM II  
  IZG -  System, X-Ray, Photofluorographic   Pilot  
892.1740 TOMOGRAPHIC X-RAY SYSTEM II  
 
  IZF -  System, X-Ray, Tomographic      
892.1750 COMPUTED TOMOGRAPHY X-RAY SYSTEM II  
 
  JAK -  System, X-Ray, Tomography, Computed      
892.1820 PNEUMOENCEPHALOGRAPHIC CHAIR II  
 
  HBK -  Chair, Pneumoencephalographic      
892.1850 RADIOGRAPHIC FILM CASSETTE II  
 
  IXA -  Cassette, Radiographic Film      
892.1860 RADIOGRAPHIC FILM/CASSETTE CHANGER II  
  KPX -  Changer, Radiographic Film/Cassette   Pilot  
892.1870 RADIOGRAPHIC FILM/CASSETTE CHANGER PROGRAMMER II  
 
  IZP -  Programmer, Changer, Film/Cassette, Radiographic      
892.1900 AUTOMATIC RADIOGRAPHIC-FILM PROCESSOR II  
 
  EGT -  Controller, Temperature, Radiographic      
  EGW -  Dryer, Film, Radiographic      
  EGY -  Processor, Radiographic-Film, Automatic, Dental      
  IXW -  Processor, Radiographic-Film, Automatic      
  IXX -  Processor, Cine Film   Pilot  
892.2030 MEDICAL IMAGE DIGITIZER II  
  NFH -  Digitizer, Images, Ophthalmic   Pilot  
  LMA -  Digitizer, Image, Radiological      
892.2040 MEDICAL IMAGE HARDCOPY DEVICE II  
PDF Guidance file for MEDICAL IMAGE HARDCOPY DEVICE (21CFR892.2040)  
  NFI -  Device, Hardcopy, Images, Ophthalmic   Pilot  
  LMC -  Camera, Multi Format, Radiological      
892.2050 PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS II  
PDF Guidance file for PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS (21CFR892.2050)  
PDF Guidance file for PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS (21CFR892.2050)  
  NFJ -  System, Image Management, Ophthalmic   Pilot  
  LLZ -  System, Image Processing, Radiological      
892.5050 MEDICAL CHARGED-PARTICLE RADIATION THERAPY SYSTEM II  
  IWK -  Cyclotron, Medical   Pilot  
  IWM -  Synchrotron, Medical   Pilot  
  IYE -  Accelerator, Linear, Medical   Pilot  
  IYG -  Betatron, Medical   Pilot  
  JAE -  Microtron, Medical   Pilot  
  LHN -  System, Radiation Therapy, Charged-Particle, Medical   Pilot  
  MUJ -  System,Planning,Radiation Therapy Treatment   Pilot  
892.5300 MEDICAL NEUTRON RADIATION THERAPY SYSTEM II  
  IWL -  System, Radiation Therapy, Neutron, Medical   Pilot  
892.5700 REMOTE CONTROLLED RADIONUCLIDE-APPLICATOR SYSTEM II  
  JAQ -  System, Applicator, Radionuclide, Remote-Controlled   Pilot  
892.5710 RADIATION THERAPY BEAM-SHAPING BLOCK II  
  IXI -  Block, Beam-Shaping, Radiation Therapy   Pilot  
892.5730 RADIONUCLIDE BRACHYTHERAPY SOURCE II  
  IWA -  Source, Wire, Iridium, Radioactive   Pilot  
  IWF -  Needle, Isotope, Gold, Titanium, Platinum   Pilot  
  IWI -  Source, Isotope, Sealed, Gold, Titanium, Platinum   Pilot  
892.5750 RADIONUCLIDE RADIATION THERAPY SYSTEM II  
  IWB -  System, Radiation Therapy, Radionuclide   Pilot  
  IWD -  Device, Beam Limiting, Teletherapy, Radionuclide   Pilot  
892.5770 POWERED RADIATION THERAPY PATIENT SUPPORT ASSEMBLY II  
  JAI -  Couch, Radiation Therapy, Powered   Pilot  
892.5840 RADIATION THERAPY SIMULATION SYSTEM II  
  KPQ -  System, Simulation, Radiation Therapy   Pilot  
892.5900 X-RAY RADIATION THERAPY SYSTEM II  
  IYC -  Generator, Orthovoltage, Therapeutic X-Ray   Pilot  
  IYD -  Generator, Low Voltage, Therapeutic X-Ray   Pilot  
  IYH -  Generator, Dermatological (Grenz Ray), Therapeutic X-Ray   Pilot  
  IYI -  Collimator, Orthovoltage, Therapeutic X-Ray   Pilot  
  IYJ -  Collimator, Low Voltage, Therapeutic X-Ray   Pilot  
  IYK -  Collimator, High Voltage, Therapeutic X-Ray   Pilot  
  IYL -  Collimator, Dermatological, Therapeutic X-Ray   Pilot  
  JAD -  System, Therapeutic, X-Ray   Pilot  
  KPZ -  Generator, High Voltage, X-Ray, Therapeutic   Pilot  
  KQA -  Device, Beam Limiting, X-Ray, Therapeutic   Pilot  
892.5930 THERAPEUTIC X-RAY TUBE HOUSING ASSEMBLY II  
 
  ITZ -  Assembly, Tube Housing, X-Ray, Therapeutic      

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