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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 K191332
Device Name XACT Robotic System
Applicant
Xact Robotics, Ltd.
8 Hatochen St., P.O. Box 3097
Caesarea,  IL 3079861
Applicant Contact Chen Levin
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 Received05/16/2019
Decision Date 10/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Clinical Trials NCT03008603
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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