K231837
- 510(k) number
- K231837
- Device name
- Brainomix 360 Triage LVO
- Applicant
- Brainomix Limited GB
- Product code
- QAS — Radiological Computer-Assisted Triage And Notificati
- Decision date
- 2023-09-28
- Date received
- 2023-06-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K231837.pdf
Official FDA record: K231837
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.