GE 1.5T SIGNA HDE MR SYSTEM— 510(k) K052978

Substantially Equivalent

Ge Medical Systems, LLC

FDA 510(k) clearance K052978 for GE 1.5T SIGNA HDE MR SYSTEM, Substantially Equivalent on 2005-11-09. Applicant: Ge Medical Systems, LLC.

Clearance details

Applicant: Ge Medical Systems, LLC
Product code: Code LNH
Advisory panel: Radiology
Date received: 2005-10-24
Decision date: 2005-11-09
Decision: Substantially Equivalent
Clearance type: Special
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.