GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM


Device Classification Name

system, x-ray, angiographic

510(k) Number K113034
Device Name GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM
Applicant
GE HEALTHCARE
9900 innovation drive
wauwatosa, 
WI 
53226

Applicant Contact carol alloian
Correspondent
GE HEALTHCARE
9900 innovation drive
wauwatosa, 
WI 
53226

Correspodent Contact carol alloian
Regulation Number 892.1600
Classification Product Code
IZI  
Date Received 10/11/2011
Decision Date 12/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No