K230355

Substantially Equivalent

Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR

Applicant: Canon Medical Systems Corporation
Product code: LNH
Advisory panel: Radiology
Date received: 2023-02-09
Decision date: 2023-08-30
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.