Subpart B—Diagnostic Devices
FDA submissions for Subpart B—Diagnostic Devices in the Radiology (RA) review panel, including product codes and regulations.
Section range: §§ 892.1000–892.2100
CFR Part: 892
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 892.1000 | 2 | 1099 |
| LNI | System, Nuclear Magnetic Resonance Spectroscopic | 892.1000 | 2 | 10 |
| MOS | Coil, Magnetic Resonance, Specialty | 892.1000 | 2 | 488 |
| OIM | Mri Disposable Kit | 892.1000 | 2 | 0 |
| PCS | Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox | 892.1001 | 2 | 3 |
| IYX | Camera, Scintillation (Gamma) | 892.1100 | 1 | 130 |
| IZC | Camera, Positron | 892.1110 | 1 | 0 |
| JAN | Counter, Whole Body, Nuclear | 892.1130 | 1 | 0 |
| KGI | Densitometer, Bone | 892.1170 | 2 | 147 |
| SAO | Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density | 892.1171 | 2 | 2 |
| MUA | Bone Sonometer | 892.1180 | 2 | 17 |
| KPS | System, Tomography, Computed, Emission | 892.1200 | 2 | 471 |
| OUO | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance | 892.1200 | 2 | 14 |
| QXL | Cabinet, Emission Computed Tomography System | 892.1200 | 2 | 1 |
| JAO | Scanner, Fluorescent | 892.1220 | 2 | 2 |
| IYW | Scanner, Rectilinear, Nuclear | 892.1300 | 1 | 4 |
| JWM | System, Tomographic, Nuclear | 892.1310 | 2 | 17 |
| IZD | Probe, Uptake, Nuclear | 892.1320 | 1 | 30 |
| JAM | Scanner, Whole Body, Nuclear | 892.1330 | 1 | 3 |
| IYZ | Bed, Scanning, Nuclear | 892.1350 | 1 | 12 |
| KPT | Calibrator, Dose, Radionuclide | 892.1360 | 2 | 32 |
| IYP | Phantom, Anthropomorphic, Nuclear | 892.1370 | 1 | 3 |
| IYQ | Phantom, Flood Source, Nuclear | 892.1380 | 1 | 0 |
| IYT | System, Rebreathing, Radionuclide | 892.1390 | 2 | 48 |
| IXD | Source, Calibration, Sealed, Nuclear | 892.1400 | 1 | 2 |
| IYY | Synchronizer, Electrocardiograph, Nuclear | 892.1410 | 1 | 3 |
| JAR | Phantom, Test-Pattern, Radionuclide | 892.1420 | 1 | 0 |
| JAF | Monitor, Ultrasonic, Nonfetal | 892.1540 | 2 | 38 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 892.1550 | 2 | 1171 |
| NCS | System, Imaging, Holography, Acoustic | 892.1550 | 2 | 3 |
| PSV | Ultrasound Bronchoscope | 892.1550 | 2 | 3 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 892.1560 | 2 | 892 |
| LWI | Ultrasound, Sinus | 892.1560 | 2 | 4 |
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 892.1560 | 2 | 46 |
| OIJ | Biopsy Needle Guide Kit | 892.1560 | 2 | 0 |
| QJG | Device System, Imaging, Tympanic Membrane And Middle Ear | 892.1560 | 2 | 2 |
| SGH | Ultrasound Imaging For Vascular Access For Hemodialysis | 892.1560 | 2 | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 892.1570 | 2 | 409 |
| MUI | Media, Coupling, Ultrasound | 892.1570 | 2 | 33 |
| OQQ | Diagnostic Ultrasonic Transducer, Robotic | 892.1570 | 2 | 1 |
| OUJ | High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist | 892.1570 | 2 | 4 |
| PSW | High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid | 892.1570 | 2 | 7 |
| SGJ | Ultrasound Imaging System For Acquiring Images At Home By Lay Users | 892.1590 | 2 | 1 |
| IZI | System, X-Ray, Angiographic | 892.1600 | 2 | 199 |
| QHA | X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device | 892.1600 | 2 | 7 |
| IZS | Aperture, Radiographic | 892.1610 | 2 | 1 |
| IZT | Cone, Radiographic | 892.1610 | 2 | 1 |
| IZW | Collimator, Automatic, Radiographic | 892.1610 | 2 | 23 |
| IZX | Collimator, Manual, Radiographic | 892.1610 | 2 | 17 |
| KPW | Device, Beam Limiting, X-Ray, Diagnostic | 892.1610 | 2 | 16 |
| IZJ | Camera, X-Ray, Fluorographic, Cine Or Spot | 892.1620 | 2 | 12 |
| IXK | System, Imaging, X-Ray, Electrostatic | 892.1630 | 2 | 14 |
| JAC | System, X-Ray, Film Marking, Radiographic | 892.1640 | 1 | 18 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 892.1650 | 2 | 300 |
| OII | Arthrogram Tray | 892.1650 | 2 | 0 |
| OIK | Radiology Dental Tray | 892.1650 | 2 | 0 |
| OWB | Interventional Fluoroscopic X-Ray System | 892.1650 | 2 | 320 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | 892.1650 | 2 | 82 |
| QHY | Solid State Fluoroscopic X-Ray Imager | 892.1650 | 2 | 0 |
| RCC | C-Arm Fluoroscopic X-Ray System | 892.1650 | 2 | 0 |
| JAB | System, X-Ray, Fluoroscopic, Non-Image-Intensified | 892.1660 | 2 | 2 |
| IXL | Device, Spot-Film | 892.1670 | 2 | 13 |
| KPR | System, X-Ray, Stationary | 892.1680 | 2 | 355 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 892.1680 | 2 | 421 |
| MWP | Cabinet, X-Ray System | 892.1680 | 2 | 27 |
| OIO | Radiographic Contrast Tray | 892.1680 | 2 | 0 |
| OIP | Radiology-Diagnostic Kit | 892.1680 | 2 | 0 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 892.1700 | 1 | 163 |
| IZH | System, X-Ray, Mammographic | 892.1710 | 2 | 176 |
| POY | Post Breast Biopsy Hemostatic Breast Compression Device | 892.1710 | 2 | 1 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 892.1715 | 2 | 60 |
| IZL | System, X-Ray, Mobile | 892.1720 | 2 | 235 |
| IZG | System, X-Ray, Photofluorographic | 892.1730 | 2 | 7 |
| OIL | Discography Kit | 892.1730 | 2 | 0 |
| IZF | System, X-Ray, Tomographic | 892.1740 | 2 | 42 |
| JAK | System, X-Ray, Tomography, Computed | 892.1750 | 2 | 819 |
| OAS | X-Ray, Tomography, Computed, Dental | 892.1750 | 2 | 133 |
| SFV | X-Ray, Computed Tomography, Cone-Beam | 892.1750 | 2 | 1 |
| ITY | Assembly, Tube Housing, X-Ray, Diagnostic | 892.1760 | 1 | 40 |
| IYB | Tube Mount, X-Ray, Diagnostic | 892.1770 | 1 | 40 |
| HBK | Chair, Pneumoencephalographic | 892.1820 | 2 | 0 |
| KXH | Cradle, Patient, Radiologic | 892.1830 | 1 | 9 |
| IWZ | Film, Radiographic | 892.1840 | 1 | 34 |
| LQA | Media, Reusable Image | 892.1840 | 1 | 1 |
| IXA | Cassette, Radiographic Film | 892.1850 | 2 | 51 |
| KPX | Changer, Radiographic Film/Cassette | 892.1860 | 2 | 26 |
| IZP | Programmer, Changer, Film/Cassette, Radiographic | 892.1870 | 2 | 10 |
| IXY | Holder, Radiographic Cassette, Wall-Mounted | 892.1880 | 1 | 21 |
| IXC | Illuminator, Radiographic-Film | 892.1890 | 1 | 18 |
| JAG | Illuminator, Radiographic-Film, Explosion-Proof | 892.1890 | 1 | 0 |
| EGT | Controller, Temperature, Radiographic | 892.1900 | 2 | 0 |
| EGW | Dryer, Film, Radiographic | 892.1900 | 2 | 2 |
| EGY | Processor, Radiographic-Film, Automatic, Dental | 892.1900 | 2 | 9 |
| IXW | Processor, Radiographic-Film, Automatic | 892.1900 | 2 | 83 |
| IXX | Processor, Cine Film | 892.1900 | 2 | 6 |
| IXJ | Grid, Radiographic | 892.1910 | 1 | 15 |
| IWY | Holder, Head, Radiographic | 892.1920 | 1 | 10 |
| IWN | Cassette, Measurement, Ardran-Crooks | 892.1940 | 1 | 1 |
| IXF | Test-Pattern, Radiographic | 892.1940 | 1 | 5 |
| IXH | Camera, Focal Spot, Radiographic | 892.1940 | 1 | 2 |
| LHO | Instrument, Quality-Assurance, Radiologic | 892.1940 | 1 | 8 |
| SHN | Calibration Software For Radiology Displays | 892.1940 | 1 | 1 |
| IXG | Phantom, Anthropomorphic, Radiographic | 892.1950 | 1 | 4 |
| EAM | Screen, Intensifying, Radiographic | 892.1960 | 1 | 35 |
| QHX | Fluoroscopic X-Ray Image Intensifier | 892.1960 | 1 | 0 |
| IXO | Synchronizer, Ecg / Respirator, Radiographic | 892.1970 | 1 | 4 |
| IXQ | Table, Radiographic, Stationary Top | 892.1980 | 2 | 27 |
| IXR | Table, Radiographic, Tilting | 892.1980 | 2 | 77 |
| IZZ | Table, Radiographic, Non-Tilting, Powered | 892.1980 | 2 | 29 |
| KXJ | Table, Radiologic | 892.1980 | 2 | 31 |
| LEK | Transilluminator (Diaphanoscope) | 892.1990 | 3 | 0 |
| LMB | Device, Digital Image Storage, Radiological | 892.2010 | 1 | 55 |
| NFF | Device, Storage, Images, Ophthalmic | 892.2010 | 1 | 1 |
| LMD | System, Digital Image Communications, Radiological | 892.2020 | 1 | 142 |
| NFG | Device, Communications, Images, Ophthalmic | 892.2020 | 1 | 0 |
| LMA | Digitizer, Image, Radiological | 892.2030 | 2 | 61 |
| NFH | Digitizer, Images, Ophthalmic | 892.2030 | 2 | 0 |
| LMC | Camera, Multi Format, Radiological | 892.2040 | 2 | 121 |
| NFI | Device, Hardcopy, Images, Ophthalmic | 892.2040 | 2 | 0 |
| LLZ | System, Image Processing, Radiological | 892.2050 | 2 | 2271 |
| NWE | Colon Computed Tomography System, Computer Aided Detection | 892.2050 | 2 | 4 |
| OEB | Lung Computed Tomography System, Computer-Aided Detection | 892.2050 | 2 | 20 |
| OMJ | Chest X-Ray Computer Aided Detection | 892.2050 | 2 | 1 |
| PGY | Display, Diagnostic Radiology | 892.2050 | 2 | 134 |
| QIH | Automated Radiological Image Processing Software | 892.2050 | 2 | 298 |
| QKB | Radiological Image Processing Software For Radiation Therapy | 892.2050 | 2 | 46 |
| QTZ | Radiological Image Processing Software For Ablation Therapy Planning And Evaluation | 892.2050 | 2 | 8 |
| QZL | Post-Ablation Tissue Response Prediction Software | 892.2052 | 2 | 2 |
| QVD | Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan | 892.2055 | 2 | 1 |
| POK | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | 892.2060 | 2 | 22 |
| MYN | Analyzer, Medical Image | 892.2070 | 2 | 48 |
| QAS | Radiological Computer-Assisted Triage And Notification Software | 892.2080 | 2 | 85 |
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | 892.2080 | 2 | 40 |
| QWO | Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. | 892.2085 | 2 | 4 |
| QBS | Radiological Computer Assisted Detection/Diagnosis Software For Fracture | 892.2090 | 2 | 10 |
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | 892.2090 | 2 | 34 |
| QJU | Image Acquisition And/Or Optimization Guided By Artificial Intelligence | 892.2100 | 2 | 8 |
