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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 K161066
Device Name SpotLight CT
Applicant
Arineta , Ltd.
15 Halamish St.
Caesarea,  IL 3088900
Applicant Contact Ehud Dafni
Correspondent
Arineta , Ltd.
15 Halamish St.
Caesarea,  IL 3088900
Correspondent Contact Ehud Dafni
Regulation Number892.1750
Classification Product Code
JAK  
Date Received04/15/2016
Decision Date 08/10/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Clinical Trials NCT02616939
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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