Panels › Radiology
Radiology devices
172 product codes reviewed by the Radiology panel. 14,743 510(k) clearances and 6,391 recalls in the FDA data, 90% of those recalls name a 510(k).
463510(k)s in 12 months
341recalls in 12 months
5,754recalls that name a 510(k)
Active product codes, Class II
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | 2 | 18 | 110 |
| QIH | Automated Radiological Image Processing Software | 2 | 90 | 1 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 2 | 28 | 60 |
| LLZ | System, Image Processing, Radiological | 2 | 48 | 25 |
| JAK | System, X-Ray, Tomography, Computed | 2 | 22 | 38 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | 54 | 4 |
| MUJ | System, Planning, Radiation Therapy Treatment | 2 | 13 | 13 |
| IYE | Accelerator, Linear, Medical | 2 | 15 | 8 |
| ITX | Transducer, Ultrasonic, Diagnostic | 2 | 6 | 13 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 10 | 9 |
| KPS | System, Tomography, Computed, Emission | 2 | 9 | 9 |
| QAS | Radiological Computer-Assisted Triage And Notification Software | 2 | 13 | 0 |
| IZL | System, X-Ray, Mobile | 2 | 7 | 5 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 2 | 4 | 7 |
| OAS | X-Ray, Tomography, Computed, Dental | 2 | 11 | 0 |
| MOS | Coil, Magnetic Resonance, Specialty | 2 | 10 | 0 |
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | 2 | 10 | 0 |
| QKB | Radiological Image Processing Software For Radiation Therapy | 2 | 10 | 0 |
| MYN | Analyzer, Medical Image | 2 | 9 | 0 |
| KPR | System, X-Ray, Stationary | 2 | 7 | 1 |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | 4 | 3 |
| LHN | System, Radiation Therapy, Charged-Particle, Medical | 2 | 4 | 3 |
| POK | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | 2 | 6 | 0 |
| PGY | Display, Diagnostic Radiology | 2 | 5 | 0 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | 3 | 1 |
| OII | Arthrogram Tray | 2 | 0 | 4 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | 2 | 3 | 1 |
| QJU | Image Acquisition And/Or Optimization Guided By Artificial Intelligence | 2 | 4 | 0 |
| IZI | System, X-Ray, Angiographic | 2 | 2 | 1 |
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | 3 | 0 |
| QBS | Radiological Computer Assisted Detection/Diagnosis Software For Fracture | 2 | 3 | 0 |
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | 2 | 3 | 0 |
| IZF | System, X-Ray, Tomographic | 2 | 1 | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 2 | 1 | 1 |
| JAD | System, Therapeutic, X-Ray | 2 | 1 | 1 |
| KGI | Densitometer, Bone | 2 | 2 | 0 |
| MUI | Media, Coupling, Ultrasound | 2 | 2 | 0 |
| NFJ | System, Image Management, Ophthalmic | 2 | 2 | 0 |
| OEB | Lung Computed Tomography System, Computer-Aided Detection | 2 | 2 | 0 |
| OUO | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance | 2 | 2 | 0 |
| OVB | Hydrogel Spacer | 2 | 2 | 0 |
| PSV | Ultrasound Bronchoscope | 2 | 2 | 0 |
| QTZ | Radiological Image Processing Software For Ablation Therapy Planning And Evaluation | 2 | 2 | 0 |
| QVA | Fludeoxyglucose F18-Guided Radiation Therapy System | 2 | 1 | 1 |
| IWB | System, Radiation Therapy, Radionuclide | 2 | 0 | 1 |
| IXI | Block, Beam-Shaping, Radiation Therapy | 2 | 1 | 0 |
| IYT | System, Rebreathing, Radionuclide | 2 | 1 | 0 |
| KXJ | Table, Radiologic | 2 | 0 | 1 |
| KXK | Source, Brachytherapy, Radionuclide | 2 | 1 | 0 |
| PZO | Software For Visualization Of Vascular Anatomy And Intravascular Devices | 2 | 1 | 0 |
| QQE | Image Management Software For Planning Of Otologic And Neurotologic Procedures | 2 | 1 | 0 |
| SAO | Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density | 2 | 1 | 0 |
| SFV | X-Ray, Computed Tomography, Cone-Beam | 2 | 1 | 0 |
| SHE | Radiological Software System For Delivery Date Prediction | 2 | 1 | 0 |
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