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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 K172983
Device Name HealthCCS
Applicant
Zebra Medical Vision, Ltd.
Shefayim Commercial Center, P.O. Box 25
Sefayim,  IL 6099000
Applicant Contact Matan Neeman
Correspondent
Zebra Medical Vision, Ltd.
Shefayim Commercial Center, P.O. Box 25
Sefayim,  IL 6099000
Correspondent Contact Flair Bar
Regulation Number892.1750
Classification Product Code
JAK  
Date Received09/27/2017
Decision Date 06/13/2018
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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