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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 tomography 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 system. II  
PDF Guidance file for Picture archiving and communications system. (21CFR892.2050)  
PDF Guidance file for Picture archiving and communications system. (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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