AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS

System, X-ray, Mammographic

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Aviva F22/mam-ch22 W/optional Cytoguide Biopsy Sys.

Pre-market Notification Details

Device IDK930282
510k NumberK930282
Device Name:AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS
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 Received1993-01-21
Decision Date1993-08-23

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