Canon Medical Informatics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 5
- Inspections
- 3
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260324 | Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning | May 22, 2026 |
| K252217 | CT VScore+ | November 28, 2025 |
| K243240 | Vitrea CT VScore | April 10, 2025 |
| K223261 | Open Rib | July 13, 2023 |
| K222662 | Vitrea CT Cardiac Analysis | October 14, 2022 |