XACT Robotic System

System, X-ray, Tomography, Computed

XACT Robotics Ltd.

The following data is part of a premarket notification filed by Xact Robotics Ltd. with the FDA for Xact Robotic System.

Pre-market Notification Details

Device IDK201586
510k NumberK201586
Device Name:XACT Robotic System
ClassificationSystem, X-ray, Tomography, Computed
Applicant XACT Robotics Ltd. 8 Hatochen Street, PO Box 3097 Caesarea,  IL 3079861
ContactChen Levin
CorrespondentJonathan S. Kahan
Hogan Lovells US LLP 555 Thirteenth Street NW Washington,  DC  20004
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-11
Decision Date2020-07-09

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