EXEL 1800 AND 1800E 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 1800 And 1800e Ct Scanner.

Pre-market Notification Details

Device IDK884670
510k NumberK884670
Device Name:EXEL 1800 AND 1800E 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 Date1989-01-18

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