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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 K160611
Device Name P-ARTIS
Applicant
P-Cure, Ltd.
12 Abba Hillel St.
Lod,  IL 7129409
Applicant Contact MICHAEL MARASH
Correspondent
Biomedical Strategy
155 Bialik St.
Ramat Gan,  IL 5252346
Correspondent Contact MERAV YARMUS
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/03/2016
Decision Date 08/08/2016
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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