FDA Product Code
FDA Product Code QFM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.2080
510(k) Clearances — 41 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253751 | CXRDetectAI | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-07-08 | Traditional | PDF ↗ |
| K252954 | MammoSightAI | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-05-04 | Traditional | PDF ↗ |
| K252482 | CogNet AI-MT+ | Medcognetics, Inc. | 2025-12-11 | Traditional | PDF ↗ |
| K250831 | Annalise Enterprise | Annalise-Ai | 2025-04-23 | Special | PDF ↗ |
| K243808 | Rayvolve PTX-PE | AZmed | 2025-03-21 | Traditional | PDF ↗ |
| K243548 | BriefCase-Triage | Aidoc Medical , Ltd. | 2024-12-11 | Special | PDF ↗ |
| K241439 | VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage | Vuno, Inc. | 2024-11-15 | Traditional | PDF ↗ |
| K240612 | CINA-VCF | Avicenna.Ai | 2024-05-31 | Traditional | PDF ↗ |
| K233108 | VinDr-Mammo | Vinbigdata Joint Stock Company | 2024-05-23 | Traditional | PDF ↗ |
| K232410 | SmartChest | Milvue | 2024-05-10 | Traditional | PDF ↗ |
| K231871 | Radify Triage | Envisionit Deepai, Ltd. | 2024-01-17 | Abbreviated | PDF ↗ |
| K223754 | BraveCX | Bering, Ltd. | 2023-11-09 | Traditional | PDF ↗ |
| K230899 | qXR-PTX-PE | Qure.Ai Technologies | 2023-08-22 | Traditional | PDF ↗ |
| K230074 | Rapid Aneurysm Triage and Notification | Ischemaview, Inc. | 2023-07-27 | Traditional | PDF ↗ |
| K222179 | Annalise Enterprise CXR Triage Trauma | Annalise-Ai Pty , Ltd. | 2023-03-28 | Traditional | PDF ↗ |
| K222268 | Annalise Enterprise CXR Triage Trauma | Annalise-Ai Pty , Ltd. | 2023-03-28 | Traditional | PDF ↗ |
| K223443 | Viz AAA | Viz. Ai, Inc. | 2023-03-17 | Traditional | PDF ↗ |
| K230020 | BriefCase | Aidoc Medical , Ltd. | 2023-02-01 | Special | PDF ↗ |
| K221868 | QOCA image Smart CXR Image Processing System | Quanta Computer, Inc. | 2023-01-27 | Traditional | PDF ↗ |
| K222692 | BriefCase | Aidoc Medical , Ltd. | 2022-12-05 | Traditional | PDF ↗ |
| K221552 | EFAI ChestSuite XR Pneumothorax Assessment System | Ever Fortune.Ai, Co., Ltd. | 2022-11-08 | Traditional | PDF ↗ |
| K220080 | CogNet QmTRIAGE | Medcognetics, Inc. | 2022-09-29 | Traditional | PDF ↗ |
| K222076 | EFAI ChestSuite XR Pleural Effusion Assessment System | Ever Fortune.Ai, Co., Ltd. | 2022-09-08 | Traditional | PDF ↗ |
| K221241 | DrAid for Radiology v1 | Vinbrain Joint Stock Company | 2022-09-01 | Traditional | PDF ↗ |
| K214043 | BriefCase | Aidoc Medical , Ltd. | 2022-03-14 | Traditional | PDF ↗ |
| K213566 | ClearRead Xray Pneumothorax | Riverain Technologies, Inc. | 2022-03-10 | Traditional | PDF ↗ |
| K213941 | Annalise Enterprise CXR Triage Pneumothorax | Annalise-Ai | 2022-02-24 | Traditional | PDF ↗ |
| K213319 | Viz ANEURYSM, Viz ANX | Viz. Ai, Inc. | 2022-02-18 | Traditional | PDF ↗ |
| K211803 | HealthPPT | Zebra Medical Vision, Ltd. | 2021-12-15 | Traditional | PDF ↗ |
| K211733 | Lunit INSIGHT CXR Triage | Lunit, Inc. | 2021-11-10 | Traditional | PDF ↗ |
| K203517 | Saige-Q | DeepHealth, Inc. | 2021-04-16 | Traditional | PDF ↗ |
| K202992 | BriefCase, RIB Fractures Triage (RibFx) | Aidoc Medical , Ltd. | 2021-04-14 | Traditional | PDF ↗ |
| K193271 | uAI EasyTriage-Rib | Shanghai United Imaging Intelligence Co., Ltd. | 2021-01-15 | Traditional | PDF ↗ |
| K200905 | HealthMammo | Zebra Medical Vision, Ltd. | 2020-07-16 | Traditional | PDF ↗ |
| K192901 | HealthVCF | Zebra Medical Vision, Ltd. | 2020-05-12 | Traditional | PDF ↗ |
| K193300 | AIMI-Triage CXR PTX | Radlogics, Inc. | 2020-04-08 | Traditional | PDF ↗ |
| K191556 | Red Dot | Behold.Ai Technologies Limited | 2020-02-28 | Traditional | PDF ↗ |
| K192320 | HealthCXR | Zebra Medical Vision, Ltd. | 2019-11-26 | Traditional | PDF ↗ |
| K183182 | Critical Care Suite | Ge Medical Systems, LLC | 2019-08-12 | Traditional | PDF ↗ |
| K190362 | HealthPNX | Zebra Medical Vision, Ltd. | 2019-05-06 | Traditional | PDF ↗ |
| K183285 | cmTriage | Curemetrix, Inc. | 2019-03-08 | Traditional | PDF ↗ |
Product code QFM · Class II · Radiology. Data: openFDA.