GYRES 2T PRESTIGE— 510(k) K945791

Name: FDA 510(k) clearance K945791
Creator: U.S. Food and Drug Administration
Published: 1995-09-19

Substantially Equivalent

Elscint, Inc.

FDA 510(k) clearance K945791 for GYRES 2T PRESTIGE, Substantially Equivalent on 1995-09-19. 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: 1994-11-25
Decision date: 1995-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hackensack, NJ, US

Download summary PDF View on FDA.gov ↗

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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.