ISG MEDICAL IMAGING FAMILY OF WORKSTATIONS (MIFW)— 510(k) K941933

Substantially Equivalent

I.S.G. Technologies, Inc.

FDA 510(k) clearance K941933 for ISG MEDICAL IMAGING FAMILY OF WORKSTATIONS (MIFW), Substantially Equivalent on 1994-07-29. Applicant: I.S.G. Technologies, Inc..

Clearance details

Applicant: I.S.G. Technologies, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1994-04-20
Decision date: 1994-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga Ontario, CA

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.