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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact JILLIAN M REED
Regulation Number892.1715
Classification Product Code
MUE  
Date Received03/15/2011
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
Predetermined Change
Control Plan Authorized		 No
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