K203225

Substantially Equivalent

Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System

Applicant: Canon Medical Systems Corporation
Product code: JAK
Advisory panel: Radiology
Date received: 2020-11-02
Decision date: 2021-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Otawara-Shi, JP

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.