DrAid for Radiology v1
A print-ready facts sheet for procurement and governance files — public records, sources included.
Vinbrain Joint Stock Company · cleared 2022-09-01 under product code QFM (Radiological Computer-Assisted Prioritization Software For Lesions).
The public record
| 510(k) number | K221241 (FDA database) |
| Device name as cleared | DrAid for Radiology v1 |
| Applicant | Vinbrain Joint Stock Company (Viet Hung Ward, Long Bien District, VN) |
| Decision | Substantially Equivalent · Traditional pathway |
| Decision date | 2022-09-01 |
| FDA product code | QFM — Radiological Computer-Assisted Prioritization Software For Lesions |
| Review panel | Radiology |
Source: openFDA 510(k) records, stored verbatim. Entry added 2026-08-29; the source link above is authoritative if any discrepancy exists.
Public disclosure beyond the clearance
| FDA clearance record | Located — linked above |
| Public model card / intended-use document | Not yet located in public sources |
| Peer-reviewed validation publication | Not yet located in public sources |
| Published subgroup / equity performance | Not yet located in public sources |
| Public monitoring or update commitments | Not yet located in public sources |
"Not yet located" is a statement about what we could find in public sources — not a statement about the product or whether such materials exist privately. Vendors: these rows update free of charge on submission of a public link — start here.
Literature mentioning this clearance number
1 publication in Europe PMC
mentions K221241, as of 2026-09-13.
| Applications of AI/ML in accelerating the development of pulmonary drug delivery system. Acta Pharm Sin B · 2026 |
Method: an automated full-text search of
Europe PMC for the exact string
K221241. A result means the publication's indexed text contains this
clearance number — nothing more. It is not a finding that the publication
validates this device, and the number of results is not a score. A clearance number appears
in the literature as a predicate citation or a comparator at least as often as it appears as
the subject of a study. Re-run this search yourself.
The vendor due-diligence checklist (interactive, stores nothing) · the contract rider (paste-ready, CC BY) · the live clearance report (weekly, citable) · the record verifier.
One email each Monday: what changed in FDA AI clearances, in two minutes. Unsubscribe any time.
Going deeper? The Compliance & Regulatory AI Toolkit ($97) is the complete evaluation workbook, and HAI-OS keeps the governance record once a tool is deployed. Vendors: a verified profile puts your website, governance contact and sealed governance record on Vinbrain Joint Stock Company’s registry page ($950/yr, human-reviewed).
This entry states public facts only and is not an evaluation or recommendation of this product. Full verification path: registry record, checklist, contract terms.