K251983
- 510(k) number
- K251983
- Device name
- Brainomix 360 Triage Stroke
- Applicant
- Brainomix Limited GB
- Product code
- QAS — Radiological Computer-Assisted Triage And Notificati
- Decision date
- 2025-08-26
- Date received
- 2025-06-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K251983.pdf
Official FDA record: K251983
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.