BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX


Device Classification Name

system, x-ray, mobile

510(k) Number K103476
Device Name BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX
Applicant
GE MEDICAL SYSTEMS, LLC
3000 n grandview blvd.
waukesha, 
WI 
53188

Applicant Contact nidhi chaudhary
Correspondent
GE MEDICAL SYSTEMS, LLC
3000 n grandview blvd.
waukesha, 
WI 
53188

Correspodent Contact nidhi chaudhary
Regulation Number 892.1720
Classification Product Code
IZL  
Date Received 11/24/2010
Decision Date 06/16/2011
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