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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 K863132
Device Name DIGITAL FLUORICON CARDIAC/VASCULAR QUANTITATIVE
Applicant
GENERAL ELECTRIC CO.
P.O. BOX 414
MILWAUKEE,  WI  53201
Applicant Contact JAMES HOWARD
Correspondent
GENERAL ELECTRIC CO.
P.O. BOX 414
MILWAUKEE,  WI  53201
Correspondent Contact JAMES HOWARD
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/15/1986
Decision Date 01/14/1987
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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