40 devices · 31 companies · 2019 to 2026
Product code QFM: Radiological Computer-Assisted Prioritization Software For Lesions
40 devices under product code QFM, 2019 to 2026, from 31 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (40 of 40 here), the regulation, and MAUDE report counts by product code.
Radiological Computer-Assisted Prioritization Software For Lesions. 21 CFR 892.2080, Class II. Radiological computer-assisted prioritization software for lesions is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| MammoSightAIK252954 · 510(k) | Neurocareai, Inc. (Dba Savelife.Ai) | Radiology | database entry | |
| CogNet AI-MT+K252482 · 510(k) | Medcognetics, Inc. | Radiology | database entry | |
| Annalise EnterpriseK250831 · 510(k) | Annalise-AI | Radiology | database entry | |
| Rayvolve PTX-PEK243808 · 510(k) | AZmed | Radiology | database entry | |
| BriefCase-TriageK243548 · 510(k) | Aidoc Medical, Ltd. | Radiology | database entry | |
| VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link TrK241439 · 510(k) | Vuno Inc. | Radiology | database entry | |
| CINA-VCFK240612 · 510(k) | Avicenna.AI | Radiology | database entry | |
| VinDr-MammoK233108 · 510(k) | VinBigData Joint Stock Company | Radiology | database entry | |
| SmartChestK232410 · 510(k) | Milvue | Radiology | database entry | |
| Radify TriageK231871 · 510(k) | Envisionit DeepAI Ltd | Radiology | database entry | |
| BraveCXK223754 · 510(k) | Bering Ltd | Radiology | database entry | |
| qXR-PTX-PEK230899 · 510(k) | Qure.ai Technologies | Radiology | database entry | |
| Rapid Aneurysm Triage and NotificationK230074 · 510(k) | iSchemaView Inc. | Radiology | database entry | |
| Annalise Enterprise CXR Triage TraumaK222179 · 510(k) | Annalise-AI Pty Ltd | Radiology | database entry | |
| Annalise Enterprise CXR Triage TraumaK222268 · 510(k) | Annalise-AI Pty Ltd | Radiology | database entry | |
| Viz AAAK223443 · 510(k) | Viz. ai, Inc. | Radiology | database entry | |
| BriefCaseK230020 · 510(k) | Aidoc Medical, Ltd. | Radiology | database entry | |
| QOCA image Smart CXR Image Processing SystemK221868 · 510(k) | Quanta Computer Inc. | Radiology | database entry | |
| BriefCaseK222692 · 510(k) | Aidoc Medical, Ltd. | Radiology | database entry | |
| EFAI ChestSuite XR Pneumothorax Assessment SysteK221552 · 510(k) | Ever Fortune AI Co., Ltd. | Radiology | database entry | |
| CogNet QmTRIAGEK220080 · 510(k) | MedCognetics, Inc. | Radiology | database entry | |
| EFAI ChestSuite XR Pleural Effusion Assessment SK222076 · 510(k) | Ever Fortune.AI Co., Ltd. | Radiology | database entry | |
| DrAid for Radiology v1K221241 · 510(k) | VinBrain Joint Stock Company | Radiology | database entry | |
| BriefCaseK214043 · 510(k) | Aidoc Medical, Ltd. | Radiology | database entry | |
| ClearRead Xray PneumothoraxK213566 · 510(k) | Riverain Technologies, Inc. | Radiology | database entry | |
| Annalise Enterprise CXR Triage PneumothoraxK213941 · 510(k) | Annalise-AI | Radiology | database entry | |
| Viz ANEURYSM, Viz ANXK213319 · 510(k) | Viz.ai, Inc. | Radiology | database entry | |
| HealthPPTK211803 · 510(k) | Zebra Medical Vision Ltd. | Radiology | database entry | |
| Lunit INSIGHT CXR TriageK211733 · 510(k) | Lunit Inc. | Radiology | database entry | |
| Saige-QK203517 · 510(k) | DeepHealth, Inc. | Radiology | database entry | |
| BriefCase, RIB Fractures TriageK202992 · 510(k) | Aidoc Medical, Ltd. | Radiology | database entry | |
| uAI EasyTriage-RibK193271 · 510(k) | Shanghai United Imaging Intelligence Co., Ltd. | Radiology | database entry | |
| HealthMammoK200905 · 510(k) | Zebra Medical Vision Ltd. | Radiology | database entry | |
| HealthVCFK192901 · 510(k) | Zebra Medical Vision Ltd. | Radiology | database entry | |
| AIMI-Triage CXR PTXK193300 · 510(k) | RADLogics, Inc. | Radiology | database entry | |
| Red DotK191556 · 510(k) | Behold.AI Technologies Limited | Radiology | database entry | |
| HealthCXRK192320 · 510(k) | Zebra Medical Vision, Ltd. | Radiology | database entry | |
| Critical Care SuiteK183182 · 510(k) | GE Medical Systems, LLC. | Radiology | database entry | |
| HealthPNXK190362 · 510(k) | Zebra Medical Vision Ltd. | Radiology | database entry | |
| cmTriageK183285 · 510(k) | CureMetrix, Inc | Radiology | database entry |
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