510(k) clearance
Vitrea Advanced Visualization, Version 7.16
- 510(k) number
- K263648
- Applicant
- Canon Medical Informatics, Inc.
- Decision date
- Oct 29, 2026
- Date received
- Oct 2, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- LLZ
- Device type
- System, Image Processing, Radiological
- Device class
- Class II
- Regulation
- 21 CFR 892.2050
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Minnetonka, MN, US