MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION

System, X-ray, Mammographic

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Mam-ch22s With Automatic Filter Selection Option.

Pre-market Notification Details

Device IDK960381
510k NumberK960381
Device Name:MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION
ClassificationSystem, X-ray, Mammographic
Applicant ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack,  NJ  07601
ContactThomas J Spackman, M.d., F.a.c.r.
CorrespondentThomas J Spackman, M.d., F.a.c.r.
ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack,  NJ  07601
Product CodeIZH  
CFR Regulation Number892.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-01-26
Decision Date1996-04-29
Summary:summary

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