FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning
K Number: K260324
·
Decision May 22, 2026
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
5
Review Days
112
Basic Information
- Device Name
- Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning
- K Number
- K260324
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Canon Medical Informatics, Inc.
- Date Received
- January 30, 2026
- Decision Date
- May 22, 2026
- Product Code
- QIH
- 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 |
|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | FDA class 2 | Radiology |
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