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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 St., P.O. Box 3097
Caesarea,  IL 3079861
Applicant Contact Dan Sigal
Correspondent
Hogan Lovells US LLP
555 Thirteenth St. 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
Predetermined Change
Control Plan Authorized		 No
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