OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM


Device Classification Name

system, x-ray, fluoroscopic, image-intensified

510(k) Number K024012
Device Name OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM
Original Applicant
GE OEC MEDICAL SYSTEMS
384 wright brothers dr.
salt lake city, 
UT 
84116

Original Contact jeff wagner
Regulation Number 892.1650
Classification Product Code
JAA  
Subsequent Product Codes
OWB   OXO  
Date Received 12/04/2002
Decision Date 03/20/2003
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