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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, digital image communications, radiological
510(k) Number K970628
Device Name GE ADVANTAGE DIGITIZER WORKSTATION
Applicant
GE MEDICAL SYSTEMS, INC.
P.O. BOX 414
MILWAUKEE,  WI  53201
Applicant Contact LARRY A KROGER, PH.D.
Correspondent
GE MEDICAL SYSTEMS, INC.
P.O. BOX 414
MILWAUKEE,  WI  53201
Correspondent Contact LARRY A KROGER, PH.D.
Regulation Number892.2020
Classification Product Code
LMD  
Date Received02/19/1997
Decision Date 05/12/1997
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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