QFM — Radiological Computer-Assisted Prioritization Software For Lesions Class II
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 |
|---|---|---|---|
| K252482 | medcognetics | CogNet AI-MT+ | December 11, 2025 |
| K250831 | annalise-ai | Annalise Enterprise | April 23, 2025 |
| K243808 | azmed | Rayvolve PTX-PE | March 21, 2025 |
| K243548 | aidoc medical | BriefCase-Triage | December 11, 2024 |
| K241439 | vuno | VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage | November 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 | January 17, 2024 |
| K223754 | bering | BraveCX | November 9, 2023 |
| K230899 | qure.ai technologies | qXR-PTX-PE | August 22, 2023 |
| K230074 | ischemaview | Rapid Aneurysm Triage and Notification | July 27, 2023 |
| K222268 | annalise-ai pty | Annalise Enterprise CXR Triage Trauma | March 28, 2023 |
| K222179 | annalise-ai pty | Annalise Enterprise CXR Triage Trauma | March 28, 2023 |
| K223443 | viz. ai | Viz AAA | March 17, 2023 |
| K230020 | aidoc medical | BriefCase | February 1, 2023 |
| K221868 | quanta computer | QOCA image Smart CXR Image Processing System | January 27, 2023 |
| K222692 | aidoc medical | BriefCase | December 5, 2022 |
| K221552 | ever fortune.ai, co | EFAI ChestSuite XR Pneumothorax Assessment System | November 8, 2022 |
| K220080 | medcognetics | CogNet QmTRIAGE | September 29, 2022 |