CARDIAC SCORING FOR CT SCANNERS

System, X-ray, Tomography, Computed

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Cardiac Scoring For Ct Scanners.

Pre-market Notification Details

Device IDK970980
510k NumberK970980
Device Name:CARDIAC SCORING FOR CT SCANNERS
ClassificationSystem, X-ray, Tomography, Computed
Applicant ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack,  NJ  07601
ContactThomas J Spackman
CorrespondentThomas J Spackman
ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack,  NJ  07601
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-03-18
Decision Date1997-05-29
Summary:summary

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