ANGIOCT OPTION FOR CT-TWIN, HELICAT & OMNIVIEW

System, X-ray, Tomography, Computed

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Angioct Option For Ct-twin, Helicat & Omniview.

Pre-market Notification Details

Device IDK932508
510k NumberK932508
Device Name:ANGIOCT OPTION FOR CT-TWIN, HELICAT & OMNIVIEW
ClassificationSystem, X-ray, Tomography, Computed
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 CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-25
Decision Date1994-07-29

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