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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 K120995
Device Name ERAD PACS/ERAD RIS/PACS/ERAD EPVLITE VIEWER SOFTWARE PRODUCT
Applicant
ERAD, INC.
23 griswold lane
winsted,  CT  06098
Contact jillian m reed
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/02/2012
Decision Date 12/03/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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