K250694
- 510(k) number
- K250694
- Device name
- Scaida BrainCT-ICH (v1.0)
- Applicant
- Mlhealth 360 CA
- Product code
- QAS — Radiological Computer-Assisted Triage And Notificati
- Decision date
- 2025-11-25
- Date received
- 2025-03-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K250694.pdf
Official FDA record: K250694
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.