FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CT VScore+
K Number: K252217
·
Decision Nov 28, 2025
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
5
Review Days
136
Basic Information
- Device Name
- CT VScore+
- K Number
- K252217
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Canon Medical Informatics, Inc.
- Date Received
- July 15, 2025
- Decision Date
- November 28, 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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Other Clearances by Canon Medical Informatics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260324 | Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning | May 22, 2026 | Substantially Equivalent |
| K243240 | Vitrea CT VScore | Apr 10, 2025 | Substantially Equivalent |
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| K222662 | Vitrea CT Cardiac Analysis | Oct 14, 2022 | Substantially Equivalent |