HISPEED DUAL


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K021491
Device Name HISPEED DUAL
Original Applicant
GE MEDICAL SYSTEMS, INC.
3000 n. grandview blvd.
waukesha, 
WI 
53188

Original Contact larry a kroger
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 05/09/2002
Decision Date 05/22/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls