SENOGRAPH DS, SENOGRAPH ESSENSTIAL


Device Classification Name

full field digital,system,x-ray,mammographic

510(k) Number K103485
Device Name SENOGRAPH DS, SENOGRAPH ESSENSTIAL
Applicant
GENERAL ELECTRIC COMPANY
3000 n. grandview blvd., w-709
waukesha, 
WI 
53188

Applicant Contact steven kachelmeyer
Correspondent
GENERAL ELECTRIC COMPANY
3000 n. grandview blvd., w-709
waukesha, 
WI 
53188

Correspodent Contact steven kachelmeyer
Regulation Number 892.1715
Classification Product Code
MUE  
Date Received 11/26/2010
Decision Date 10/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No