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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 K210085
Device Name HealthCCSng
Applicant
Zebra Medical Vision Ltd.
Shefayim Commercial Center, PO Box 25
Shefayim,  IL 6099000
Applicant Contact Shlomit Cymbalista
Correspondent
Zebra Medical Vision Ltd.
Shefayim Commercial Center, PO Box 25
Shefayim,  IL 6099000
Correspondent Contact Shlomit Cymbalista
Regulation Number892.1750
Classification Product Code
JAK  
Date Received01/13/2021
Decision Date 09/15/2021
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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