Radify Triage (Envisionit DeepAI Ltd) was cleared through 510(k) (substantially equivalent) by FDA on Jan 17, 2024 under submission K231871, product code QFM. Review panel: Radiology.
| FDA submission number | K231871 |
|---|---|
| Pathway | 510(k) |
| Company | Envisionit DeepAI Ltd |
| Review panel (specialty) | Radiology |
| FDA decision date | 2024-01-17 |
| Decision | Substantially Equivalent |
| Product code | QFM |
| Classification | Radiological Computer-Assisted Prioritization Software For Lesions |
| Device class | Class II |
| Regulation number | 892.2080 |
| Review time (calendar days) | 205 |
| Applicant country | GB |
Official FDA database record (decision summary) · FDA AI-enabled device list
FAQ
Is Radify Triage FDA authorized?
Yes. Radify Triage appears on FDA's AI-enabled medical device list. It was cleared through 510(k) (substantially equivalent) on Jan 17, 2024 (K231871).
Which FDA pathway was used for Radify Triage?
510(k), submission number K231871, decision: Substantially Equivalent, after 205 calendar days of review.
What is the FDA product code for Radify Triage?
QFM (Radiological Computer-Assisted Prioritization Software For Lesions), Class II, regulation 892.2080.
Other AI devices with product code QFM
- MammoSightAI (Neurocareai, Inc. (Dba Savelife.Ai), K252954, May 4, 2026)
- CogNet AI-MT+ (Medcognetics, Inc., K252482, Dec 11, 2025)
- Annalise Enterprise (Annalise-AI, K250831, Apr 23, 2025)
- Rayvolve PTX-PE (AZmed, K243808, Mar 21, 2025)
- BriefCase-Triage (Aidoc Medical, Ltd., K243548, Dec 11, 2024)
- VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage (Vuno Inc., K241439, Nov 15, 2024)
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Data as of: FDA AI-enabled device list through Jun 29, 2026, joined to openFDA. Informational only; verify against the FDA record.