Subpart F—Therapeutic Devices
FDA submissions for Subpart F—Therapeutic Devices in the Radiology (RA) review panel, including product codes and regulations.
Section range: §§ 892.5050–892.5930
CFR Part: 892
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| IWK | Cyclotron, Medical | 892.5050 | 2 | 0 |
| IWM | Synchrotron, Medical | 892.5050 | 2 | 1 |
| IYE | Accelerator, Linear, Medical | 892.5050 | 2 | 731 |
| IYG | Betatron, Medical | 892.5050 | 2 | 0 |
| JAE | Microtron, Medical | 892.5050 | 2 | 0 |
| LHN | System, Radiation Therapy, Charged-Particle, Medical | 892.5050 | 2 | 90 |
| MUJ | System, Planning, Radiation Therapy Treatment | 892.5050 | 2 | 252 |
| MWW | Accessory - Film Dosimetry System | 892.5050 | 2 | 0 |
| NZT | Dosimeter, Ionizing Radiation, Implanted | 892.5050 | 2 | 7 |
| QVA | Fludeoxyglucose F18-Guided Radiation Therapy System | 892.5060 | 2 | 2 |
| IWL | System, Radiation Therapy, Neutron, Medical | 892.5300 | 2 | 4 |
| IWJ | System, Applicator, Radionuclide, Manual | 892.5650 | 1 | 36 |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 892.5700 | 2 | 206 |
| IXI | Block, Beam-Shaping, Radiation Therapy | 892.5710 | 2 | 51 |
| PCT | Prostate Immobilizer Rectal Balloon | 892.5720 | 2 | 5 |
| OVB | Hydrogel Spacer | 892.5725 | 2 | 7 |
| QUV | Phase-Changing Fiducial Marker For Radiation Therapy | 892.5727 | 2 | 1 |
| IWA | Source, Wire, Iridium, Radioactive | 892.5730 | 2 | 8 |
| IWF | Needle, Isotope, Gold, Titanium, Platinum | 892.5730 | 2 | 0 |
| IWG | Seed, Isotope, Gold, Titanium, Platinum | 892.5730 | 2 | 3 |
| IWI | Source, Isotope, Sealed, Gold, Titanium, Platinum | 892.5730 | 2 | 6 |
| KXK | Source, Brachytherapy, Radionuclide | 892.5730 | 2 | 151 |
| NMP | Needle, Isotope, Reprocessed | 892.5730 | 2 | 0 |
| OIN | Prostate Seeding Kit | 892.5730 | 2 | 0 |
| ONL | Conformal Brachytherapy Source | 892.5730 | 2 | 1 |
| QXR | Vaginal Hydrogel Packing System | 892.5735 | 2 | 1 |
| IWH | Source, Teletherapy, Radionuclide | 892.5740 | 1 | 0 |
| IWB | System, Radiation Therapy, Radionuclide | 892.5750 | 2 | 48 |
| IWD | Device, Beam Limiting, Teletherapy, Radionuclide | 892.5750 | 2 | 1 |
| JAI | Couch, Radiation Therapy, Powered | 892.5770 | 2 | 32 |
| IWE | Monitor, Patient Position, Light-Beam | 892.5780 | 1 | 28 |
| RGC | X-Ray Field Indicator Light (Laser) | 892.5780 | 1 | 0 |
| QRN | Radiation Therapy Marking Device | 892.5785 | 2 | 2 |
| KPQ | System, Simulation, Radiation Therapy | 892.5840 | 2 | 70 |
| IYC | Generator, Orthovoltage, Therapeutic X-Ray | 892.5900 | 2 | 0 |
| IYD | Generator, Low Voltage, Therapeutic X-Ray | 892.5900 | 2 | 1 |
| IYH | Generator, Dermatological (Grenz Ray), Therapeutic X-Ray | 892.5900 | 2 | 1 |
| IYI | Collimator, Orthovoltage, Therapeutic X-Ray | 892.5900 | 2 | 2 |
| IYJ | Collimator, Low Voltage, Therapeutic X-Ray | 892.5900 | 2 | 0 |
| IYK | Collimator, High Voltage, Therapeutic X-Ray | 892.5900 | 2 | 0 |
| IYL | Collimator, Dermatological, Therapeutic X-Ray | 892.5900 | 2 | 1 |
| JAD | System, Therapeutic, X-Ray | 892.5900 | 2 | 53 |
| KPZ | Generator, High Voltage, X-Ray, Therapeutic | 892.5900 | 2 | 3 |
| KQA | Device, Beam Limiting, X-Ray, Therapeutic | 892.5900 | 2 | 4 |
| ITZ | Assembly, Tube Housing, X-Ray, Therapeutic | 892.5930 | 2 | 0 |
