SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM— 510(k) K992135

Substantially Equivalent

Ge Medical Systems, Inc.

FDA 510(k) clearance K992135 for SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM, Substantially Equivalent on 1999-09-08. Applicant: Ge Medical Systems, Inc..

Clearance details

Applicant: Ge Medical Systems, Inc.
Product code: Code LNH
Advisory panel: Radiology
Date received: 1999-06-24
Decision date: 1999-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
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.