MODEL #801GE1500 PEDIATRIC ARRAY COIL— 510(k) K951649

Substantially Equivalent

Medic, Inc.

FDA 510(k) clearance K951649 for MODEL #801GE1500 PEDIATRIC ARRAY COIL, Substantially Equivalent on 1995-06-22. Applicant: Medic, Inc..

Clearance details

Applicant: Medic, Inc.
Product code: Code LNH
Advisory panel: Radiology
Date received: 1995-04-10
Decision date: 1995-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, NE, 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.