Vitrea Software Toshiba Package, VSTP-001A— 510(k) K151091

Substantially Equivalent

Toshibamedical Systems Corporation

FDA 510(k) clearance K151091 for Vitrea Software Toshiba Package, VSTP-001A, Substantially Equivalent on 2015-07-13. Applicant: Toshibamedical Systems Corporation.

Clearance details

Applicant: Toshibamedical Systems Corporation
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2015-04-23
Decision date: 2015-07-13
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.