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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 K173041
Device Name 3DIEMME RealGUIDE
Applicant
3Diemme , Ltd.
Via Risorgimento 9
Cantu,  IT 22063
Applicant Contact Alessandro Montroni
Correspondent
Registar Corp
144 Research Dr.
Hampton,  VA  23666
Correspondent Contact Lara Luzak
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/28/2017
Decision Date 12/20/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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