QFM — Radiological Computer-Assisted Prioritization Software For Lesions Class II
FDA product code QFM covers "Radiological Computer-Assisted Prioritization Software For Lesions", a Class II medical device regulated under 21 CFR 892.2080. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QFM
- Device Class
- Class II
- Regulation Number
- 892.2080
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253751 | Neurocareai, Inc. (Dba Savelife.Ai) | CXRDetectAI | Jul 8, 2026 |
| K252954 | Neurocareai, Inc. (Dba Savelife.Ai) | MammoSightAI | May 4, 2026 |
| K252482 | Medcognetics | CogNet AI-MT+ | Dec 11, 2025 |
| K250831 | Annalise-Ai | Annalise Enterprise | Apr 23, 2025 |
| K243808 | Azmed | Rayvolve PTX-PE | Mar 21, 2025 |
| K243548 | Aidoc Medical | BriefCase-Triage | Dec 11, 2024 |
| K241439 | Vuno | VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage | Nov 15, 2024 |
| K240612 | Avicenna.Ai | CINA-VCF | May 31, 2024 |
| K233108 | Vinbigdata Joint Stock | VinDr-Mammo | May 23, 2024 |
| K232410 | Milvue | SmartChest | May 10, 2024 |
| K231871 | Envisionit Deepai | Radify Triage | Jan 17, 2024 |
| K223754 | Bering | BraveCX | Nov 9, 2023 |
| K230899 | Qure.Ai Technologies | qXR-PTX-PE | Aug 22, 2023 |
| K230074 | Ischemaview | Rapid Aneurysm Triage and Notification | Jul 27, 2023 |
| K222268 | Annalise-Ai Pty | Annalise Enterprise CXR Triage Trauma | Mar 28, 2023 |
| K222179 | Annalise-Ai Pty | Annalise Enterprise CXR Triage Trauma | Mar 28, 2023 |
| K223443 | Viz. Ai | Viz AAA | Mar 17, 2023 |
| K230020 | Aidoc Medical | BriefCase | Feb 1, 2023 |
| K221868 | Quanta Computer | QOCA image Smart CXR Image Processing System | Jan 27, 2023 |
| K222692 | Aidoc Medical | BriefCase | Dec 5, 2022 |