GE 0.2T SIGNA PROFILE/I MR SYSTEM— 510(k) K033168

Substantially Equivalent

General Electric Co.

FDA 510(k) clearance K033168 for GE 0.2T SIGNA PROFILE/I MR SYSTEM, Substantially Equivalent on 2003-10-10. Applicant: General Electric Co..

Clearance details

Applicant: General Electric Co.
Product code: Code LNH
Advisory panel: Radiology
Date received: 2003-09-30
Decision date: 2003-10-10
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.