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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Display, Diagnostic Radiology
510(k) Number K161229
Device Name Mammo Tomosynthesis (MDMG-5221)
Applicant
BARCO N.V.
PRESIDENT KENNEDYPARK 35
Kortrijk,  BE 8500
Applicant Contact Lieven De Wandel
Correspondent
BARCO N.V.
PRESIDENT KENNEDYPARK 35
Kortrijk,  BE 8500
Correspondent Contact Lieven De Wandel
Regulation Number892.2050
Classification Product Code
PGY  
Date Received05/02/2016
Decision Date 05/18/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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