1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT— 510(k) K121676

Substantially Equivalent

Ge Medical Systems, LLC

FDA 510(k) clearance K121676 for 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT, Substantially Equivalent on 2012-09-20. Applicant: Ge Medical Systems, LLC.

Clearance details

Applicant: Ge Medical Systems, LLC
Product code: Code LNH
Advisory panel: Radiology
Date received: 2012-06-07
Decision date: 2012-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

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Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

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.