510(k) K263648
K263648 is an FDA 510(k) premarket notification submitted by Canon Medical Informatics, Inc. for the device "Vitrea Advanced Visualization, Version 7.16". The FDA issued a decision of Substantially Equivalent on Oct 29, 2026. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Canon Medical Informatics, Inc. has 5 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 29, 2026
- Date Received
- Oct 2, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
- 510(k)