SENOGRAPHE DS, SENOGRAPHE ESSENTIAL


Device Classification Name

full field digital,system,x-ray,mammographic

510(k) Number K110798
Device Name SENOGRAPHE DS, SENOGRAPHE ESSENTIAL
Applicant
GENERAL ELECTRIC COMPANY
3000 north grandview blvd.
waukesha, 
WI 
53188

Applicant Contact steven kachelmeyer
Correspondent
GENERAL ELECTRIC COMPANY
3000 north grandview blvd.
waukesha, 
WI 
53188

Correspodent Contact steven kachelmeyer
Regulation Number 892.1715
Classification Product Code
MUE  
Date Received 03/22/2011
Decision Date 12/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No