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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 K163158
Device Name MEDSYNAPSE Zero Footprint Viewer
Applicant
Medsynaptic Private, Ltd.
5th Floor, Mantri Galleria, Off S.B. Rd.
Model Colony, Shivaji Nagar
Pune,  IN 411016
Applicant Contact Ashish Dhawad
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/10/2016
Decision Date 12/02/2016
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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