Scaida BrainCT-ICH (v1.0)— 510(k) K250694
Substantially EquivalentMlhealth 360
FDA 510(k) clearance K250694 for Scaida BrainCT-ICH (v1.0), Substantially Equivalent on 2025-11-25. Applicant: Mlhealth 360. Device class: 2.
Clearance details
- Applicant
- Mlhealth 360
- Product code
- Code QAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.2080
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Surrey, CA
Recent devices under product code QAS
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