DYNAMIC WEDGE— 510(k) K970564

Substantially Equivalent

Mitsubishi Electronics America, Inc.

FDA 510(k) clearance K970564 for DYNAMIC WEDGE, Substantially Equivalent on 1997-05-12. Applicant: Mitsubishi Electronics America, Inc..

Clearance details

Applicant: Mitsubishi Electronics America, Inc.
Product code: Code IYE
Advisory panel: Radiology
Date received: 1997-02-13
Decision date: 1997-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

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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.