Vitrea Software Package, VSTP-002A— 510(k) K223336

Substantially Equivalent

Canon Medical Systems Corporation

FDA 510(k) clearance K223336 for Vitrea Software Package, VSTP-002A, Substantially Equivalent on 2023-01-09. Applicant: Canon Medical Systems Corporation.

Clearance details

Applicant: Canon Medical Systems Corporation
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2022-11-01
Decision date: 2023-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Otawara-Shi, JP

Download summary PDF View on FDA.gov ↗

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.