CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS— 510(k) K982004

Substantially Equivalent

General Electric Co.

FDA 510(k) clearance K982004 for CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS, Substantially Equivalent on 1998-08-18. Applicant: General Electric Co..

Clearance details

Applicant: General Electric Co.
Product code: Code JAK
Advisory panel: Radiology
Date received: 1998-06-08
Decision date: 1998-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

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Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

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.