Transparency Registry · K251873
Saige-Dx
DeepHealth, Inc. · cleared 2025-08-11 under product code QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer).
The public record
| 510(k) number | K251873 (FDA database) |
| Device name as cleared | Saige-Dx |
| Applicant | DeepHealth, Inc. (Somerville, MA, US) |
| Decision | Substantially Equivalent · Special pathway |
| Decision date | 2025-08-11 |
| FDA product code | QDQ — Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer |
| 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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acts, and HAI-OS keeps the governance record once a
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evaluation or recommendation of this product.