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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 K173605
Device Name iQMR
Applicant
Medic Vision - Imaging Solutions Ltd
3 Hayozma Street
tirat carmel,  IL 3903203
Applicant Contact eyal aharon
Correspondent
Dan Laor
6 Sireni
haifa,  IL 3297206
Correspondent Contact dan laor
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/21/2017
Decision Date 03/08/2018
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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