Transparency Registry · K222179
Annalise Enterprise CXR Triage Trauma
Annalise-Ai Pty , Ltd. · cleared 2023-03-28 under product code QFM (Radiological Computer-Assisted Prioritization Software For Lesions).
The public record
| 510(k) number | K222179 (FDA database) |
| Device name as cleared | Annalise Enterprise CXR Triage Trauma |
| Applicant | Annalise-Ai Pty , Ltd. (Sydney, AU) |
| Decision | Substantially Equivalent · Traditional pathway |
| Decision date | 2023-03-28 |
| 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.
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