GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM— 510(k) K030874

Substantially Equivalent

General Electric Co.

FDA 510(k) clearance K030874 for GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM, Substantially Equivalent on 2003-03-28. Applicant: General Electric Co..

Clearance details

Applicant: General Electric Co.
Product code: Code LNH
Advisory panel: Radiology
Date received: 2003-03-20
Decision date: 2003-03-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Milwaukee, 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.