SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS— 510(k) K971668

Substantially Equivalent

GE Medical Systems

FDA 510(k) clearance K971668 for SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS, Substantially Equivalent on 1997-07-24. Applicant: GE Medical Systems.

Clearance details

Applicant: GE Medical Systems
Product code: Code LNH
Advisory panel: Radiology
Date received: 1997-05-06
Decision date: 1997-07-24
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.