FDA-cleared K250694
Scaida BrainCT-ICH (v1.0)
Mlhealth 360
Authorized purpose: Non-contrast head CT triage for suspected intracranial hemorrhage in adults aged 22 and older.
- Modality
- CT/CTA
- Anatomy
- Brain/Head
- Decision
- 2025-11-25
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Mlhealth 360
Authorized purpose: Non-contrast head CT triage for suspected intracranial hemorrhage in adults aged 22 and older.