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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K142923
Device Name TraumaCad Mobile Release 1.0
Applicant
Voyant Health Ltd
35 Efal Street
Petach-Tikva,  IL 4951132
Applicant Contact Yael Guttentag
Correspondent
Voyant Health Ltd
35 Efal Street
Petach-Tikva,  IL 4951132
Correspondent Contact Yael Guttentag
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/08/2014
Decision Date 03/05/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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