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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 K160001
Device Name TraumaCad Mobile Release 2.0
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 Received01/04/2016
Decision Date 02/12/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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