EINSTEIN PROCESSING AND REVIEW WORKSTATION


definition

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 Number 892.2050
Classification Product Code
LLZ  
Date Received 02/07/2000
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