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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 K153331
Device Name SafeCT-29
Applicant
Medic Vision Imaging Solutions
3 Yozma
Tirat Carmel,  IL 3903203
Applicant Contact EYAL AHARON
Correspondent
Medic Vision Imaging Solutions
6 Sireni
Haifa,  IL 32972
Correspondent Contact DAN LAOR
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/19/2015
Decision Date 05/17/2016
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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