ArtPIX DRF

System, X-ray, Fluoroscopic, Image-intensified

CMT Medical Technologies Ltd

The following data is part of a premarket notification filed by Cmt Medical Technologies Ltd with the FDA for Artpix Drf.

Pre-market Notification Details

Device IDK202235
510k NumberK202235
Device Name:ArtPIX DRF
ClassificationSystem, X-ray, Fluoroscopic, Image-intensified
Applicant CMT Medical Technologies Ltd 7/2 Hacarmel St., POB 111, Industrial Park Yokneam Ilit,  IL 20692
ContactDror Wertman
CorrespondentDror Wertman
CMT Medical Technologies Ltd 7/2 Hacarmel St., POB 111, Industrial Park Yokneam Ilit,  IL 20692
Product CodeJAA  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-07
Decision Date2020-09-03

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