E-SPEED EBT SCANNER SYSTEM


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K022794
Device Name E-SPEED EBT SCANNER SYSTEM
Original Applicant
GE IMATRON
389 oyster point blvd.
south san fransisco, 
CA 
94080

Original Contact kerry a spear
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 08/23/2002
Decision Date 10/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No