QFM
41 FDA 510(k) clearances · Product code
144 daysmedian time to decision
262 days90th percentile
41clearances measured
FDA profile
- Official device name
- Radiological Computer-Assisted Prioritization Software For Lesions
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2080
- Medical specialty
- Radiology
- FDA definition
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CXRDetectAI (K253751) | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-07-08 |
| MammoSightAI (K252954) | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-05-04 |
| CogNet AI-MT+ (K252482) | Medcognetics, Inc. | 2025-12-11 |
| Annalise Enterprise (K250831) | Annalise-Ai | 2025-04-23 |
| Rayvolve PTX-PE (K243808) | AZmed | 2025-03-21 |
| BriefCase-Triage (K243548) | Aidoc Medical , Ltd. | 2024-12-11 |
| VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage (K241439) | Vuno, Inc. | 2024-11-15 |
| CINA-VCF (K240612) | Avicenna.Ai | 2024-05-31 |
| VinDr-Mammo (K233108) | Vinbigdata Joint Stock Company | 2024-05-23 |
| SmartChest (K232410) | Milvue | 2024-05-10 |
| Radify Triage (K231871) | Envisionit Deepai, Ltd. | 2024-01-17 |
| BraveCX (K223754) | Bering, Ltd. | 2023-11-09 |
| qXR-PTX-PE (K230899) | Qure.Ai Technologies | 2023-08-22 |
| Rapid Aneurysm Triage and Notification (K230074) | Ischemaview, Inc. | 2023-07-27 |
| Annalise Enterprise CXR Triage Trauma (K222179) | Annalise-Ai Pty , Ltd. | 2023-03-28 |
| Annalise Enterprise CXR Triage Trauma (K222268) | Annalise-Ai Pty , Ltd. | 2023-03-28 |
| Viz AAA (K223443) | Viz. Ai, Inc. | 2023-03-17 |
| BriefCase (K230020) | Aidoc Medical , Ltd. | 2023-02-01 |
| QOCA image Smart CXR Image Processing System (K221868) | Quanta Computer, Inc. | 2023-01-27 |
| BriefCase (K222692) | Aidoc Medical , Ltd. | 2022-12-05 |
| EFAI ChestSuite XR Pneumothorax Assessment System (K221552) | Ever Fortune.Ai, Co., Ltd. | 2022-11-08 |
| CogNet QmTRIAGE (K220080) | Medcognetics, Inc. | 2022-09-29 |
| EFAI ChestSuite XR Pleural Effusion Assessment System (K222076) | Ever Fortune.Ai, Co., Ltd. | 2022-09-08 |
| DrAid for Radiology v1 (K221241) | Vinbrain Joint Stock Company | 2022-09-01 |
| BriefCase (K214043) | Aidoc Medical , Ltd. | 2022-03-14 |
| ClearRead Xray Pneumothorax (K213566) | Riverain Technologies, Inc. | 2022-03-10 |
| Annalise Enterprise CXR Triage Pneumothorax (K213941) | Annalise-Ai | 2022-02-24 |
| Viz ANEURYSM, Viz ANX (K213319) | Viz. Ai, Inc. | 2022-02-18 |
| HealthPPT (K211803) | Zebra Medical Vision, Ltd. | 2021-12-15 |
| Lunit INSIGHT CXR Triage (K211733) | Lunit, Inc. | 2021-11-10 |
| Saige-Q (K203517) | DeepHealth, Inc. | 2021-04-16 |
| BriefCase, RIB Fractures Triage (RibFx) (K202992) | Aidoc Medical , Ltd. | 2021-04-14 |
| uAI EasyTriage-Rib (K193271) | Shanghai United Imaging Intelligence Co., Ltd. | 2021-01-15 |
| HealthMammo (K200905) | Zebra Medical Vision, Ltd. | 2020-07-16 |
| HealthVCF (K192901) | Zebra Medical Vision, Ltd. | 2020-05-12 |
| AIMI-Triage CXR PTX (K193300) | Radlogics, Inc. | 2020-04-08 |
| Red Dot (K191556) | Behold.Ai Technologies Limited | 2020-02-28 |
| HealthCXR (K192320) | Zebra Medical Vision, Ltd. | 2019-11-26 |
| Critical Care Suite (K183182) | Ge Medical Systems, LLC | 2019-08-12 |
| HealthPNX (K190362) | Zebra Medical Vision, Ltd. | 2019-05-06 |
| cmTriage (K183285) | Curemetrix, Inc. | 2019-03-08 |
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