MAM-3RM-A MAMMOGRAPHIC X-RAY SYSTEM

System, X-ray, Mammographic

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Mam-3rm-a Mammographic X-ray System.

Pre-market Notification Details

Device IDK912974
510k NumberK912974
Device Name:MAM-3RM-A MAMMOGRAPHIC X-RAY SYSTEM
ClassificationSystem, X-ray, Mammographic
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 CodeIZH  
CFR Regulation Number892.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-08
Decision Date1991-09-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.