A BREAST COIL FOR THE GYREX 2T-DIX

System, Nuclear Magnetic Resonance Imaging

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for A Breast Coil For The Gyrex 2t-dix.

Pre-market Notification Details

Device IDK923897
510k NumberK923897
Device Name:A BREAST COIL FOR THE GYREX 2T-DIX
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 Received1992-08-04
Decision Date1992-10-21

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