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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 K082318
Device Name CENTRICITY PACS IW
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 Received08/13/2008
Decision Date 08/25/2008
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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