Radiological Computer-Assisted Prioritization Software For Lesions
FDA product code QFM · Class II (moderate risk) · 21 CFR 892.2080 · Radiology
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.
41510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Zebra Medical Vision, Ltd. 5
- Aidoc Medical , Ltd. 5
- Annalise-Ai Pty , Ltd. 4
- Neurocareai, Inc. (Dba Savelife.Ai) 2
- Viz. Ai, Inc. 2
- Medcognetics, Inc. 2
- Ever Fortune.Ai, Co., Ltd. 2
- Vinbrain Joint Stock Company 1
- Envisionit Deepai, Ltd. 1
- Bering, Ltd. 1
- Qure.Ai Technologies 1
- Ischemaview, Inc. 1
- Quanta Computer, Inc. 1
- Behold.Ai Technologies Limited 1
- Riverain Technologies, Inc. 1
- Curemetrix, Inc. 1
- Lunit, Inc. 1
- DeepHealth, Inc. 1
- GE Medical Systems, LLC 1
- Shanghai United Imaging Intelligence Co., Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253751 | CXRDetectAIQFM · Traditional | Neurocareai, Inc. (Dba Savelife.Ai) | 07/08/2026SE |
| K252954 | MammoSightAIQFM · Traditional | Neurocareai, Inc. (Dba Savelife.Ai) | 05/04/2026SE |
| K252482 | CogNet AI-MT+QFM · Traditional | Medcognetics, Inc. | 12/11/2025SE |
| K250831 | Annalise EnterpriseQFM · Special | Annalise-Ai | 04/23/2025SE |
| K243808 | Rayvolve PTX-PEQFM · Traditional | AZmed | 03/21/2025SE |
| K243548 | BriefCase-TriageQFM · Special | Aidoc Medical , Ltd. | 12/11/2024SE |
| K241439 | VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link TriageQFM · Traditional | Vuno, Inc. | 11/15/2024SE |
| K240612 | Cina-VcfQFM · Traditional | Avicenna.Ai | 05/31/2024SE |
| K233108 | VinDr-MammoQFM · Traditional | Vinbigdata Joint Stock Company | 05/23/2024SE |
| K232410 | SmartChestQFM · Traditional | Milvue | 05/10/2024SE |
| K231871 | Radify TriageQFM · Abbreviated | Envisionit Deepai, Ltd. | 01/17/2024SE |
| K223754 | BraveCXQFM · Traditional | Bering, Ltd. | 11/09/2023SE |
| K230899 | qXR-PTX-PEQFM · Traditional | Qure.Ai Technologies | 08/22/2023SE |
| K230074 | Rapid Aneurysm Triage and NotificationQFM · Traditional | Ischemaview, Inc. | 07/27/2023SE |
| K222268 | Annalise Enterprise CXR Triage TraumaQFM · Traditional | Annalise-Ai Pty , Ltd. | 03/28/2023SE |
| K222179 | Annalise Enterprise CXR Triage TraumaQFM · Traditional | Annalise-Ai Pty , Ltd. | 03/28/2023SE |
| K223443 | Viz AAAQFM · Traditional | Viz. Ai, Inc. | 03/17/2023SE |
| K230020 | BriefCaseQFM · Special | Aidoc Medical , Ltd. | 02/01/2023SE |
| K221868 | QOCA image Smart CXR Image Processing SystemQFM · Traditional | Quanta Computer, Inc. | 01/27/2023SE |
| K222692 | BriefCaseQFM · Traditional | Aidoc Medical , Ltd. | 12/05/2022SE |
| K221552 | EFAI ChestSuite XR Pneumothorax Assessment SystemQFM · Traditional | Ever Fortune.Ai, Co., Ltd. | 11/08/2022SE |
| K220080 | CogNet QmTRIAGEQFM · Traditional | Medcognetics, Inc. | 09/29/2022SE |
| K222076 | EFAI ChestSuite XR Pleural Effusion Assessment SystemQFM · Traditional | Ever Fortune.Ai, Co., Ltd. | 09/08/2022SE |
| K221241 | DrAid for Radiology v1QFM · Traditional | Vinbrain Joint Stock Company | 09/01/2022SE |
| K214043 | BriefCaseQFM · Traditional | Aidoc Medical , Ltd. | 03/14/2022SE |
| K213566 | ClearRead Xray PneumothoraxQFM · Traditional | Riverain Technologies, Inc. | 03/10/2022SE |
| K213941 | Annalise Enterprise CXR Triage PneumothoraxQFM · Traditional | Annalise-Ai | 02/24/2022SE |
| K213319 | Viz ANEURYSM, Viz ANXQFM · Traditional | Viz. Ai, Inc. | 02/18/2022SE |
| K211803 | HealthPPTQFM · Traditional | Zebra Medical Vision, Ltd. | 12/15/2021SE |
| K211733 | Lunit INSIGHT CXR TriageQFM · Traditional | Lunit, Inc. | 11/10/2021SE |
| K203517 | Saige-QQFM · Traditional | DeepHealth, Inc. | 04/16/2021SE |
| K202992 | BriefCase, RIB Fractures Triage (RibFx)QFM · Traditional | Aidoc Medical , Ltd. | 04/14/2021SE |
| K193271 | uAI EasyTriage-RibQFM · Traditional | Shanghai United Imaging Intelligence Co., Ltd. | 01/15/2021SE |
| K200905 | HealthMammoQFM · Traditional | Zebra Medical Vision, Ltd. | 07/16/2020SE |
| K192901 | HealthVCFQFM · Traditional | Zebra Medical Vision, Ltd. | 05/12/2020SE |
| K193300 | AIMI-Triage CXR PTXQFM · Traditional | Radlogics, Inc. | 04/08/2020SE |
| K191556 | Red DotQFM · Traditional | Behold.Ai Technologies Limited | 02/28/2020SE |
| K192320 | HealthCXRQFM · Traditional | Zebra Medical Vision, Ltd. | 11/26/2019SE |
| K183182 | Critical Care SuiteQFM · Traditional | Ge Medical Systems, LLC | 08/12/2019SE |
| K190362 | HealthPNXQFM · Traditional | Zebra Medical Vision, Ltd. | 05/06/2019SE |
| K183285 | cmTriageQFM · Traditional | Curemetrix, Inc. | 03/08/2019SE |