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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 K161382
Device Name LVivo Software Application
Applicant
DIACARDIO, LTD.
HAENERGIA STREET 77
Be’er Sheva,  IL 8496500
Applicant Contact Michal Yaacobi
Correspondent
MEDICSENSE, USA
291 HILLSIDE AVENUE
Somerset,  MA  02726
Correspondent Contact George J. Hattub
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/18/2016
Decision Date 07/28/2016
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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