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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 K902428
Device Name INTEGRATED DIAGNOSTIC SYSTEM W/ADD'L OPTIONS
Applicant
GE MEDICAL SYSTEMS
PO BOX 414
MILWAUKEE,  WI  53201
Applicant Contact KROGER, PHD
Correspondent
GE MEDICAL SYSTEMS
PO BOX 414
MILWAUKEE,  WI  53201
Correspondent Contact KROGER, PHD
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/31/1990
Decision Date 11/19/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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