Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4— 510(k) K161009

Substantially Equivalent

Toshibamedical Systems Corporation

FDA 510(k) clearance K161009 for Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4, Substantially Equivalent on 2016-07-22. Applicant: Toshibamedical Systems Corporation.

Clearance details

Applicant: Toshibamedical Systems Corporation
Product code: Code JAK
Advisory panel: Radiology
Date received: 2016-04-11
Decision date: 2016-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Otawara-Shi, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

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.