FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
Scaida BrainCT-ICH (v1.0)
K Number: K250694
·
Decision Nov 25, 2025
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
85
Applicant Total
1
Review Days
263
Basic Information
- Device Name
- Scaida BrainCT-ICH (v1.0)
- K Number
- K250694
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2080
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mlhealth 360
- Date Received
- March 7, 2025
- Decision Date
- November 25, 2025
- Product Code
- QAS
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QAS | Radiological Computer-Assisted Triage And Notification Software | FDA class 2 | Radiology |
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