TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERA

System, Tomography, Computed, Emission

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Transact: Attenuation Correction System For The Apex Cardial Gamma Camera.

Pre-market Notification Details

Device IDK952674
510k NumberK952674
Device Name:TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERA
ClassificationSystem, Tomography, Computed, Emission
Applicant ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack,  NJ  07601
ContactKathleen Murray
CorrespondentKathleen Murray
ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack,  NJ  07601
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-12
Decision Date1995-09-26

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