FDA product code QFM: Radiological Computer-Assisted Prioritization Software For Lesions
QFM is the FDA product code for radiological computer-assisted prioritization software for lesions. It is a Class II device, regulated under 21 CFR 892.2080 and reviewed by the Radiology panel. FDA has cleared 41 510(k) submissions under QFM, 28 in the last five years, from 27 different applicants. The average 510(k) review took 163 days (median 144); 161 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Radiological Computer-Assisted Prioritization Software For Lesions |
| Device class | Class II |
| Regulation | 21 CFR 892.2080 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for QFM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 4 | 135 |
| 2020 | 4 | 176 |
| 2021 | 5 | 219 |
| 2022 | 9 | 123 |
| 2023 | 8 | 191 |
| 2024 | 6 | 168 |
| 2025 | 3 | 87 |
| 2026 | 2 | 228 |
Compare with all 510(k) review times · Search every QFM clearance
Top QFM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aidoc Medical , Ltd. | 5 | 2024-12-11 |
| Zebra Medical Vision, Ltd. | 5 | 2021-12-15 |
| Neurocareai, Inc. (Dba Savelife.Ai) | 2 | 2026-07-08 |
| Medcognetics, Inc. | 2 | 2025-12-11 |
| Annalise-Ai | 2 | 2025-04-23 |
22 more applicants have QFM clearances. See the full list in Caduvo.
Most recent QFM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253751 | Neurocareai, Inc. (Dba Savelife.Ai) | CXRDetectAI | 2026-07-08 | 225 |
| K252954 | Neurocareai, Inc. (Dba Savelife.Ai) | MammoSightAI | 2026-05-04 | 230 |
| K252482 | Medcognetics, Inc. | CogNet AI-MT+ | 2025-12-11 | 126 |
| K250831 | Annalise-Ai | Annalise Enterprise | 2025-04-23 | 35 |
| K243808 | AZmed | Rayvolve PTX-PE | 2025-03-21 | 100 |
Recalls for QFM devices
openFDA lists no recalls for product code QFM.
Frequently asked questions
What is FDA product code QFM?
QFM is the FDA product code for radiological computer-assisted prioritization software for lesions. It is a Class II device, regulated under 21 CFR 892.2080 and reviewed by the Radiology panel.
What device class is QFM?
Class II, regulation 21 CFR 892.2080. Typical premarket route: 510(k).
How long does a 510(k) take for product code QFM?
Across 41 cleared submissions the average was 163 days from receipt to decision (median 144).
Which companies have the most QFM clearances?
Aidoc Medical , Ltd. (5); Zebra Medical Vision, Ltd. (5); Neurocareai, Inc. (Dba Savelife.Ai) (2); Medcognetics, Inc. (2); Annalise-Ai (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QFM
- Run a recall and safety report across every QFM manufacturer
- Watch product code QFM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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