Radiological Computer-Assisted Prioritization Software For Lesions
Regulation 892.2080
3510(k)s in 12 months (41 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QFM
| Company | 510(k)s | Recalls |
|---|---|---|
| Aidoc Medical , Ltd. | 5 | 0 |
| Zebra Medical Vision, Ltd. | 5 | 0 |
| Annalise-Ai | 4 | 0 |
| Ever Fortune.Ai, Co., Ltd. | 2 | 0 |
| Medcognetics, Inc. | 2 | 0 |
| Neurocareai, Inc. (Dba Savelife.Ai) | 2 | 0 |
| Viz. Ai, Inc. | 2 | 0 |
| Avicenna.Ai | 1 | 0 |
| AZmed | 1 | 0 |
| Behold.Ai Technologies Limited | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 8, 2026 | K253751 | CXRDetectAI Neurocareai, Inc. (Dba Savelife.Ai) | QFM |
| May 4, 2026 | K252954 | MammoSightAI Neurocareai, Inc. (Dba Savelife.Ai) | QFM |
| Dec 11, 2025 | K252482 | CogNet AI-MT+ Medcognetics, Inc. | QFM |
| Apr 23, 2025 | K250831 | Annalise Enterprise Annalise-Ai, AU | QFM |
| Mar 21, 2025 | K243808 | Rayvolve PTX-PE AZmed, FR | QFM |
| Dec 11, 2024 | K243548 | BriefCase-Triage Aidoc Medical , Ltd., IL | QFM |
| Nov 15, 2024 | K241439 | VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage Vuno, Inc., KR | QFM |
| May 31, 2024 | K240612 | CINA-VCF Avicenna.Ai, FR | QFM |
| May 23, 2024 | K233108 | VinDr-Mammo Vinbigdata Joint Stock Company, VN | QFM |
| May 10, 2024 | K232410 | SmartChest Milvue, FR | QFM |
| Jan 17, 2024 | K231871 | Radify Triage Envisionit Deepai, Ltd., GB | QFM |
| Nov 9, 2023 | K223754 | BraveCX Bering, Ltd., GB | QFM |
| Aug 22, 2023 | K230899 | qXR-PTX-PE Qure.Ai Technologies, IN | QFM |
| Jul 27, 2023 | K230074 | Rapid Aneurysm Triage and Notification Ischemaview, Inc. | QFM |
| Mar 28, 2023 | K222268 | Annalise Enterprise CXR Triage Trauma Annalise-Ai Pty , Ltd., AU | QFM |
| Mar 28, 2023 | K222179 | Annalise Enterprise CXR Triage Trauma Annalise-Ai Pty , Ltd., AU | QFM |
| Mar 17, 2023 | K223443 | Viz AAA Viz. Ai, Inc. | QFM |
| Feb 1, 2023 | K230020 | BriefCase Aidoc Medical , Ltd., IL | QFM |
| Jan 27, 2023 | K221868 | QOCA image Smart CXR Image Processing System Quanta Computer, Inc., TW | QFM |
| Dec 5, 2022 | K222692 | BriefCase Aidoc Medical , Ltd., IL | QFM |
| Nov 8, 2022 | K221552 | EFAI ChestSuite XR Pneumothorax Assessment System Ever Fortune.Ai, Co., Ltd., TW | QFM |
| Sep 29, 2022 | K220080 | CogNet QmTRIAGE Medcognetics, Inc. | QFM |
| Sep 8, 2022 | K222076 | EFAI ChestSuite XR Pleural Effusion Assessment System Ever Fortune.Ai, Co., Ltd., TW | QFM |
| Sep 1, 2022 | K221241 | DrAid for Radiology v1 Vinbrain Joint Stock Company, VN | QFM |
| Mar 14, 2022 | K214043 | BriefCase Aidoc Medical , Ltd., IL | QFM |
| Mar 10, 2022 | K213566 | ClearRead Xray Pneumothorax Riverain Technologies, Inc. | QFM |
| Feb 24, 2022 | K213941 | Annalise Enterprise CXR Triage Pneumothorax Annalise-Ai, AU | QFM |
| Feb 18, 2022 | K213319 | Viz ANEURYSM, Viz ANX Viz. Ai, Inc. | QFM |
| Dec 15, 2021 | K211803 | HealthPPT Zebra Medical Vision, Ltd., IL | QFM |
| Nov 10, 2021 | K211733 | Lunit INSIGHT CXR Triage Lunit, Inc., KR | QFM |
| Apr 16, 2021 | K203517 | Saige-Q DeepHealth, Inc. | QFM |
| Apr 14, 2021 | K202992 | BriefCase, RIB Fractures Triage (RibFx) Aidoc Medical , Ltd., IL | QFM |
| Jan 15, 2021 | K193271 | uAI EasyTriage-Rib Shanghai United Imaging Intelligence Co., Ltd., CN | QFM |
| Jul 16, 2020 | K200905 | HealthMammo Zebra Medical Vision, Ltd., IL | QFM |
| May 12, 2020 | K192901 | HealthVCF Zebra Medical Vision, Ltd., IL | QFM |
| Apr 8, 2020 | K193300 | AIMI-Triage CXR PTX Radlogics, Inc. | QFM |
| Feb 28, 2020 | K191556 | Red Dot Behold.Ai Technologies Limited, GB | QFM |
| Nov 26, 2019 | K192320 | HealthCXR Zebra Medical Vision, Ltd., IL | QFM |
| Aug 12, 2019 | K183182 | Critical Care Suite Ge Medical Systems, LLC | QFM |
| May 6, 2019 | K190362 | HealthPNX Zebra Medical Vision, Ltd., IL | QFM |
| Mar 8, 2019 | K183285 | cmTriage Curemetrix, Inc. | QFM |
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