KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM


Device Classification Name

full field digital,system,x-ray,mammographic

510(k) Number K110717
Device Name KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM
Applicant
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
25 walnut street
monroe, 
CT 
06468

Applicant Contact jillian m reed
Correspondent
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
25 walnut street
monroe, 
CT 
06468

Correspodent Contact jillian m reed
Regulation Number 892.1715
Classification Product Code
MUE  
Date Received 03/15/2011
Decision Date 12/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No