Aquilion Prime SP, TSX-303B/1, v8.4— 510(k) K172188

Substantially Equivalent

Toshiba Medical Systems Coroporation

FDA 510(k) clearance K172188 for Aquilion Prime SP, TSX-303B/1, v8.4, Substantially Equivalent on 2017-10-06. Applicant: Toshiba Medical Systems Coroporation.

Clearance details

Applicant: Toshiba Medical Systems Coroporation
Product code: Code JAK
Advisory panel: Radiology
Date received: 2017-07-20
Decision date: 2017-10-06
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.