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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 November 29, 2021

This page lists devices currently eligible for third-party review under the FDA's 510(k) Third Party Review Program, formally, the Accredited Persons Program. Premarket Notifications ["510(k)'s"] for devices on this list can be submitted to FDA-recognized 3P510K Review Organizations (Accredited Persons) in lieu of FDA. Information on the 510(k) Third Party Review Program, including links to this page and to a list of accredited persons, is available at the 510(k) Third Party Review Program website.

How to use the list of eligible devices

The list has four 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 provides a link to available standards to assist manufacturers in the preparation-and 3P510k review organizations in the review-of 510(k)s for eligible devices.

Some important exceptions to the list

Please see the 510(k) Third Party Review Program Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations for exceptions to the list.


Radiology

help
Section No. Regulation Name
Product Code-Device Name
Class
Available
Standards
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  
  IYX -  Camera, Scintillation (Gamma)  
892.1110 Positron camera. I  
  IZC -  Camera, Positron  
892.1170 Bone densitometer. II  
  KGI -  Densitometer, Bone  
892.1200 Emission computed tomography system. II  
  KPS -  System, Tomography, Computed, Emission  
892.1220 Fluorescent scanner. II  
  JAO -  Scanner, Fluorescent  
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  
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  
  NQQ -  System, Imaging, Optical Coherence Tomography (Oct)  
892.1570 Diagnostic ultrasonic transducer. II  
  OUJ -  High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist  
  ITX -  Transducer, Ultrasonic, Diagnostic  
  MUI -  Media, Coupling, Ultrasound  
  OQQ -  Diagnostic Ultrasonic Transducer, Robotic  
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  
  OWB -  Interventional Fluoroscopic X-Ray System  
  OXO -  Image-Intensified Fluoroscopic X-Ray System, Mobile  
  RCC -  C-Arm Fluoroscopic X-Ray System  
892.1660 Non-image-intensified fluoroscopic x-ray system. II  
  JAB -  System, X-Ray, Fluoroscopic, Non-Image-Intensified  
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  
892.1710 Mammographic x-ray system. II  
  IZH -  System, X-Ray, Mammographic  
892.1715 Full-field digital mammography system. II  
  MUE -  Full Field Digital, 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  
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  
892.2050 Medical image management and processing system. II  
  NFJ -  System, Image Management, Ophthalmic  
  LLZ -  System, Image Processing, Radiological  
  PGY -  Display, Diagnostic Radiology  
892.5710 Radiation therapy beam-shaping block. II  
  IXI -  Block, Beam-Shaping, Radiation Therapy  
892.5720 Rectal balloon for prostate immobilization. II  
  PCT -  Prostate Immobilizer Rectal Balloon  
892.5730 Radionuclide brachytherapy source. II  
  IWA -  Source, Wire, Iridium, Radioactive  
  IWF -  Needle, Isotope, Gold, Titanium, Platinum  
  IWI -  Source, Isotope, Sealed, Gold, Titanium, Platinum  
892.5750 Radionuclide radiation therapy system. II  
  IWD -  Device, Beam Limiting, Teletherapy, Radionuclide  
892.5770 Powered radiation therapy patient support assembly. II  
  JAI -  Couch, Radiation Therapy, Powered  
892.5840 Radiation therapy simulation system. II  
  KPQ -  System, Simulation, Radiation Therapy  
892.5900 X-ray radiation therapy system. II  
  IYC -  Generator, Orthovoltage, Therapeutic X-Ray  
  IYD -  Generator, Low Voltage, Therapeutic X-Ray  
  IYH -  Generator, Dermatological (Grenz Ray), Therapeutic X-Ray  
  IYI -  Collimator, Orthovoltage, Therapeutic X-Ray  
  IYJ -  Collimator, Low Voltage, Therapeutic X-Ray  
  IYK -  Collimator, High Voltage, Therapeutic X-Ray  
  IYL -  Collimator, Dermatological, Therapeutic X-Ray  
  KPZ -  Generator, High Voltage, X-Ray, Therapeutic  
  KQA -  Device, Beam Limiting, X-Ray, Therapeutic  
892.5930 Therapeutic x-ray tube housing assembly. II  
  ITZ -  Assembly, Tube Housing, X-Ray, Therapeutic  

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