Vitrea Advanced Visualization, Version 7.16— 510(k) K263648

Name: FDA 510(k) clearance K263648
Creator: U.S. Food and Drug Administration
Published: 2026-10-29

Substantially Equivalent

Canon Medical Informatics, Inc.

FDA 510(k) clearance K263648 for Vitrea Advanced Visualization, Version 7.16, Substantially Equivalent on 2026-10-29. Applicant: Canon Medical Informatics, Inc.. Device class: 2.

Clearance details

Applicant: Canon Medical Informatics, Inc.
Product code: Product code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-10-02
Decision date: 2026-10-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.