Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition— 510(k) K191777

Substantially Equivalent

Ge Medical Systems, LLC

FDA 510(k) clearance K191777 for Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition, Substantially Equivalent on 2019-07-26. Applicant: Ge Medical Systems, LLC.

Clearance details

Applicant: Ge Medical Systems, LLC
Product code: Code JAK
Advisory panel: Radiology
Date received: 2019-07-02
Decision date: 2019-07-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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.