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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, x-ray, tomography, computed
510(k) Number K213759
Device Name XACT Robotic System, ACE Model
Applicant
XACT Robotics, Ltd.
8 Hatochen Street, PO Box 3097
Caesarea,  IL 3079861
Applicant Contact Dan Sigal
Correspondent
Hogan Lovells US LLP
555 Thirteenth Street NW
Washington,  DC  20004
Correspondent Contact Jonathan S Kahan
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/30/2021
Decision Date 09/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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