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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
Original Applicant
GE MEDICAL SYSTEMS F.I. HAIFA
p.o. box 170
tirat hacarmel,  IL 30200
Original 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
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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