K251645

Substantially Equivalent

Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP

Applicant: Canon Medical Systems Corporation
Product code: JAK
Advisory panel: Radiology
Date received: 2025-05-29
Decision date: 2025-09-26
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.