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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
Applicant Contact JILLIAN M REED
Correspondent
ERAD, INC.
23 GRISWOLD LANE
WINSTED,  CT  06098
Correspondent Contact JILLIAN M REED
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/02/2012
Decision Date 12/03/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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