PRECISION 500D R&F X-RAY SYSTEM


Device Classification Name

system, x-ray, fluoroscopic, image-intensified

510(k) Number K081091
Device Name PRECISION 500D R&F X-RAY SYSTEM
Applicant
GE HEALTHCARE
3000 n grandview blvd.
w-709
waukesha, 
WI 
53188

Applicant Contact michael petrowski
Correspondent
GE HEALTHCARE
3000 n grandview blvd.
w-709
waukesha, 
WI 
53188

Correspodent Contact michael petrowski
Regulation Number 892.1650
Classification Product Code
JAA  
Date Received 04/16/2008
Decision Date 06/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls