MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS— 510(k) K122450

Substantially Equivalent

Mitsubishi Heavy Industries, Ltd.

FDA 510(k) clearance K122450 for MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS, Substantially Equivalent on 2012-10-03. Applicant: Mitsubishi Heavy Industries, Ltd..

Clearance details

Applicant: Mitsubishi Heavy Industries, Ltd.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2012-08-13
Decision date: 2012-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hiroshima-Shi, JP

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Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.