SECTRA MICRODOSE MAMMOGRAPHY


Device Classification Name

full field digital,system,x-ray,mammographic

510(k) Number K110025
Device Name SECTRA MICRODOSE MAMMOGRAPHY
Applicant
SECTRA IMTEC AB
teknikeingen 20
linkoping, 

SE

58330

Applicant Contact alexander asklov
Correspondent
SECTRA IMTEC AB
teknikeingen 20
linkoping, 

SE

58330

Correspodent Contact alexander asklov
Regulation Number 892.1715
Classification Product Code
MUE  
Date Received 01/03/2011
Decision Date 04/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No