EXEL 1002 CT SCANNER

System, X-ray, Tomography, Computed

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Exel 1002 Ct Scanner.

Pre-market Notification Details

Device IDK884668
510k NumberK884668
Device Name:EXEL 1002 CT SCANNER
ClassificationSystem, X-ray, Tomography, Computed
Applicant ELSCINT, INC. 930 COMMONWEALTH AVE. Boston,  MA  02215
ContactSobel
CorrespondentSobel
ELSCINT, INC. 930 COMMONWEALTH AVE. Boston,  MA  02215
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-11-08
Decision Date1988-12-30

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