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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 K093247
Device Name MEDSYNAPSE PACS SOFTWARE
Applicant
Medsynaptic Private, Ltd.
8726 Ferrara Ct.
Naples,  FL  34114
Applicant Contact DANIEL KAMM
Correspondent
Medsynaptic Private, Ltd.
8726 Ferrara Ct.
Naples,  FL  34114
Correspondent Contact DANIEL KAMM
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/15/2009
Decision Date 12/02/2009
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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