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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 K072986
Device Name INTEGRADWEB PACS SYSTEM
Applicant
GE HEALTHCARE
25 WALNUT STREET
MONROE,  CT  06468
Applicant Contact JILLIAN M REED
Correspondent
GE HEALTHCARE
25 WALNUT STREET
MONROE,  CT  06468
Correspondent Contact JILLIAN M REED
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/23/2007
Decision Date 11/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
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