GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0

System, Nuclear Magnetic Resonance Imaging

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Gyrex V-dix & 2t-dix Software Version 3.0.

Pre-market Notification Details

Device IDK925985
510k NumberK925985
Device Name:GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack,  NJ  07601
ContactRochelle M Sobel
CorrespondentRochelle M Sobel
ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack,  NJ  07601
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-25
Decision Date1993-10-07

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