OPTIMA XR120


Device Classification Name

device, spot-film

510(k) Number K111304
Device Name OPTIMA XR120
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 892.1670
Classification Product Code
IXL  
Subsequent Product Code
MQB  
Date Received 05/09/2011
Decision Date 07/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No