510(k) K203323— Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR

Substantially Equivalent

Canon Medical Systems Corporation

Clearance details

Applicant: Canon Medical Systems Corporation
Product code: Code LNH
Advisory panel: Radiology
Date received: 2020-11-12
Decision date: 2021-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Otawara-Shi, JP

Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

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.