3D PROCESSING OPTIONS FOR GYREX

System, Nuclear Magnetic Resonance Imaging

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for 3d Processing Options For Gyrex.

Pre-market Notification Details

Device IDK915579
510k NumberK915579
Device Name:3D PROCESSING OPTIONS FOR GYREX
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack,  NJ  07601
ContactRochelle Sobel
CorrespondentRochelle 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 Received1991-12-13
Decision Date1992-02-18

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