GE ADVANTAGE DICOM CR REPROCESSING STATION— 510(k) K955185

Substantially Equivalent

GE Medical Systems

FDA 510(k) clearance K955185 for GE ADVANTAGE DICOM CR REPROCESSING STATION, Substantially Equivalent on 1996-01-03. Applicant: GE Medical Systems.

Clearance details

Applicant: GE Medical Systems
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1995-11-13
Decision date: 1996-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

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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.