Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1— 510(k) K170177

Substantially Equivalent

Toshibamedical Systems Corporation

FDA 510(k) clearance K170177 for Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1, Substantially Equivalent on 2017-06-30. Applicant: Toshibamedical Systems Corporation.

Clearance details

Applicant: Toshibamedical Systems Corporation
Product code: Code JAK
Advisory panel: Radiology
Date received: 2017-01-19
Decision date: 2017-06-30
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.