3D PROCESSING OPTIONS FOR GYREX— 510(k) K915579

Name: FDA 510(k) clearance K915579
Creator: U.S. Food and Drug Administration
Published: 1992-02-18

Substantially Equivalent

Elscint, Inc.

FDA 510(k) clearance K915579 for 3D PROCESSING OPTIONS FOR GYREX, Substantially Equivalent on 1992-02-18. Applicant: Elscint, Inc.. Device class: 2.

Clearance details

Applicant: Elscint, Inc.
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 1991-12-13
Decision date: 1992-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hackensack, NJ, US

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K980306 — GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP1998-04-02
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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.