Transparency Registry · K250694
Scaida BrainCT-ICH (v1.0)
Mlhealth 360 · cleared 2025-11-25 under product code QAS (Radiological Computer-Assisted Triage And Notification Software).
The public record
| 510(k) number | K250694 (FDA database) |
| Device name as cleared | Scaida BrainCT-ICH (v1.0) |
| Applicant | Mlhealth 360 (Surrey, CA) |
| Decision | Substantially Equivalent · Traditional pathway |
| Decision date | 2025-11-25 |
| FDA product code | QAS — Radiological Computer-Assisted Triage And Notification Software |
| 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.
Buying or governing this category?
The procurement instruments are free, the
agent privileging framework covers AI that
acts, and HAI-OS keeps the governance record once a
tool is deployed. This entry states public facts only and is not an
evaluation or recommendation of this product.