ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY

System, X-ray, Mammographic

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Advanced Automatic Detector Selection Option For Glory.

Pre-market Notification Details

Device IDK983313
510k NumberK983313
Device Name:ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY
ClassificationSystem, X-ray, Mammographic
Applicant ELSCINT, INC. 22 PARIS AVE. Rockleigh,  NJ  07647
ContactSteven M Kay
CorrespondentSteven M Kay
ELSCINT, INC. 22 PARIS AVE. Rockleigh,  NJ  07647
Product CodeIZH  
CFR Regulation Number892.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-21
Decision Date1998-12-11
Summary:summary

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