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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 K000395
Device Name EINSTEIN PROCESSING AND REVIEW WORKSTATION
Applicant
GE MEDICAL SYSTEMS F.I. HAIFA
P.O. BOX 170
TIRAT HACARMEL,  IL 30200
Applicant Contact DAN LAOR
Correspondent
GE MEDICAL SYSTEMS F.I. HAIFA
P.O. BOX 170
TIRAT HACARMEL,  IL 30200
Correspondent Contact DAN LAOR
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/07/2000
Decision Date 05/03/2000
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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