INSTRUMENTARIUM MEGA4— 510(k) K912963

Substantially Equivalent

Instrumentarium Imaging, Inc.

FDA 510(k) clearance K912963 for INSTRUMENTARIUM MEGA4, Substantially Equivalent on 1991-09-30. Applicant: Instrumentarium Imaging, Inc..

Clearance details

Applicant: Instrumentarium Imaging, Inc.
Product code: Code LNH
Advisory panel: Radiology
Date received: 1991-07-08
Decision date: 1991-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

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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.