SPECIAL PURPOSE COILS FOR GYREX V— 510(k) K915598

Substantially Equivalent

Elscint, Inc.

FDA 510(k) clearance K915598 for SPECIAL PURPOSE COILS FOR GYREX V, Substantially Equivalent on 1992-01-31. Applicant: Elscint, Inc..

Clearance details

Applicant: Elscint, Inc.
Product code: Code LNH
Advisory panel: Radiology
Date received: 1991-12-13
Decision date: 1992-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hackensack, NJ, US

Download summary PDF View on FDA.gov ↗

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.