Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i— 510(k) K192832

Substantially Equivalent

Canon Medical Systems Corporation

FDA 510(k) clearance K192832 for Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i, Substantially Equivalent on 2020-02-21. Applicant: Canon Medical Systems Corporation.

Clearance details

Applicant: Canon Medical Systems Corporation
Product code: Code JAK
Advisory panel: Radiology
Date received: 2019-10-02
Decision date: 2020-02-21
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.