FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
SCENARIA View Phase 5.0
K Number: K250370
·
Decision May 20, 2025
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
795
Applicant Total
41
Review Days
99
Basic Information
- Device Name
- SCENARIA View Phase 5.0
- K Number
- K250370
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- FUJIFILM Corporation
- Date Received
- February 10, 2025
- Decision Date
- May 20, 2025
- Product Code
- JAK
- 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | FDA class 2 | Radiology |
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