MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION— 510(k) K053356

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K053356 for MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION, Substantially Equivalent on 2006-04-19. Applicant: Ge Medical Systems Information Technologies.

Clearance details

Applicant: Ge Medical Systems Information Technologies
Product code: Code DXJ
Advisory panel: Cardiovascular
Date received: 2005-12-02
Decision date: 2006-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

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Adverse events under product code DXJ

product code DXJ

Death: 2
Total: 2

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.