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Radiology devices
172 product codes reviewed by the Radiology panel. 14,743 510(k) clearances and 6,387 recalls in the FDA data, 90% of those recalls name a 510(k).
475510(k)s in 12 months
354recalls in 12 months
5,750recalls that name a 510(k)
Codes with the most recalls
| Code | Device | All time | 12 months |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 872 | 38 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 723 | 60 |
| OWB | Interventional Fluoroscopic X-Ray System | 637 | 109 |
| IYE | Accelerator, Linear, Medical | 563 | 8 |
| LLZ | System, Image Processing, Radiological | 561 | 24 |
| KPS | System, Tomography, Computed, Emission | 450 | 9 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 300 | 10 |
| MUJ | System, Planning, Radiation Therapy Treatment | 270 | 13 |
| IZI | System, X-Ray, Angiographic | 259 | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 223 | 4 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 195 | 2 |
| IZL | System, X-Ray, Mobile | 173 | 6 |
| KPR | System, X-Ray, Stationary | 170 | 3 |
| ITX | Transducer, Ultrasonic, Diagnostic | 147 | 13 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 83 | 9 |
Active product codes
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | 2 | 19 | 109 |
| QIH | Automated Radiological Image Processing Software | 2 | 91 | 1 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 2 | 28 | 60 |
| LLZ | System, Image Processing, Radiological | 2 | 50 | 24 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | 56 | 10 |
| JAK | System, X-Ray, Tomography, Computed | 2 | 22 | 38 |
| MUJ | System, Planning, Radiation Therapy Treatment | 2 | 13 | 13 |
| IYE | Accelerator, Linear, Medical | 2 | 16 | 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 |
| OAS | X-Ray, Tomography, Computed, Dental | 2 | 11 | 3 |
| QAS | Radiological Computer-Assisted Triage And Notification Software | 2 | 14 | 0 |
| IWO | Apron, Protective | 1 | 0 | 13 |
| IZL | System, X-Ray, Mobile | 2 | 7 | 6 |
| KPR | System, X-Ray, Stationary | 2 | 7 | 3 |
| MOS | Coil, Magnetic Resonance, Specialty | 2 | 10 | 0 |
| MYN | Analyzer, Medical Image | 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 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 2 | 4 | 5 |
| 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 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 2 | 1 | 4 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | 3 | 2 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | 2 | 4 | 1 |
| PGY | Display, Diagnostic Radiology | 2 | 5 | 0 |
| OII | Arthrogram Tray | 2 | 0 | 4 |
| QJU | Image Acquisition And/Or Optimization Guided By Artificial Intelligence | 2 | 4 | 0 |
| IZF | System, X-Ray, Tomographic | 2 | 2 | 1 |
| 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 |
| IYX | Camera, Scintillation (Gamma) | 1 | 0 | 2 |
| 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 |
| IWE | Monitor, Patient Position, Light-Beam | 1 | 0 | 1 |
| IXI | Block, Beam-Shaping, Radiation Therapy | 2 | 1 | 0 |
| IXR | Table, Radiographic, Tilting | 2 | 0 | 1 |
| IYB | Tube Mount, X-Ray, Diagnostic | 1 | 0 | 1 |
| IYT | System, Rebreathing, Radionuclide | 2 | 1 | 0 |
| IZD | Probe, Uptake, Nuclear | 1 | 0 | 1 |
| JAC | System, X-Ray, Film Marking, Radiographic | 1 | 0 | 1 |
| 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 |
| QWO | Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. | 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 |
| SHN | Calibration Software For Radiology Displays | 1 | 1 | 0 |
Latest recalls in this panel
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion S. Model Number: 722285. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7 M20. Model Numbers: 722079, 722224, 722282. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7 M12. Model Numbers: 722078, 722223. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7 B20. Model Numbers: 722068, 722226. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7 B12. Model Numbers: 722067, 722225. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 5 M20. Model Numbers: 722228, 722281. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 5 M12. Model Number: 722227. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 3 M15. Model Number: 722064, 722222, 722280. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 3 M12. Model Numbers: 722063, 722221. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | Canon Medical System, USA, INC. ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM
REF: INFX-8000V Open, Classified |
OWB | K203551 K233107 |
| Oct 27, 2026 | Canon Medical System, USA, INC. ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM
REF: INFX-8000F Open, Classified |
OWB | K182415 |
| Oct 27, 2026 | Canon Medical System, USA, INC. ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM
REF: INFX-8000C Open, Classified |
OWB | K210900 |
| Oct 26, 2026 | Philips North America Model Number: 712010. Open, Classified |
IZL | K233678 |
| Oct 23, 2026 | ZIEHM-ORTHOSCAN INC Orthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020 Open, Classified |
OXO | K243452 |
| Oct 22, 2026 | Solstice Corporation Xact mole marker for mammography
Model/Catalog Number: M15RM Open, Classified |
JAC | None listed |
| Oct 16, 2026 | Philips Ultrasound, LLC Philips Lumify Diagnostic Ultrasound System Open, Classified |
IYN | K242519 K242670 |
| Oct 15, 2026 | INTELERAD MEDICAL SYSTEMS INCORPORATED IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through R128, PACS-5-4-1-R66 through R101, PACS-5-5-1-R50 through R89, PACS-5-6-1-R41 through R81, Open, Classified |
LLZ | K192176 |
| Oct 7, 2026 | Canon Medical System, USA, INC. Alphenix INFX-8000C/B5 Open, Classified |
OWB | K210900 |
| Oct 2, 2026 | PHILIPS MEDICAL SYSTEMS Spectral CT and Spectral CT 7500 RT;
Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.);
Model Numbers: 1. 728333 (U.S. and Outside U.S.), 2. 728340 (Outside U.S.), 3. 728344 ( Open, Classified |
JAK | K244008 |
| Sep 29, 2026 | Philips North America Llc Philips Medical Systems
Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333 Open, Classified |
JAK | K244008 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI 780 Open, Classified |
KPS | K172143 |
| Sep 25, 2026 | Philips North America Evolution upgrade 1.5T amd Evolution upgrade 3.0T;
Model number (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782166 (1.5T), 4. 782201(1.5T), 5. 782117 (3.0T), 6. 782143 (3.0T), 7. 782162 (3.0T);
Sof Open, Classified |
LNH | K213583 K223458 +2 |
| Sep 25, 2026 | Philips North America Upgrade to MR 7700;
Model number (REF): 782130;
Software Versions: R11, R12 and R13; Open, Classified |
LNH | K230972 |
| Sep 25, 2026 | Philips North America Upgrade dStream;
Model number (REF): 782127;
Software Versions: R11, R12 and R13; Open, Classified |
LNH | K213516 |
| Sep 25, 2026 | Philips North America SmartPath to MR 7700;
Model number (REF): 1. 782178, 2. 782207;
Software Versions: R11, R12 and R13; Open, Classified |
LNH | K223458 K251397 |
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