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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 K083018
Device Name CENTRICITY PACS WEB DIAGNOSTIC
Applicant
GE HEALTHCARE DYNAMIC IMAGING SOLUTIONS
25 WALNUT ST.
MONROE,  CT  06468
Applicant Contact JILLIAN M REED
Correspondent
GE HEALTHCARE DYNAMIC IMAGING SOLUTIONS
25 WALNUT ST.
MONROE,  CT  06468
Correspondent Contact JILLIAN M REED
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/09/2008
Decision Date 11/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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