FDA 510(k) Application Details - K161229

Device Classification Name	More FDA Info for this Device
510(K) Number	K161229
Device Name	Mammo Tomosynthesis (MDMG-5221)
Applicant	BARCO N.V. PRESIDENT KENNEDYPARK 35 Kortrijk 8500 BE Other 510(k) Applications for this Company
Contact	Lieven De Wandel Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/2016
Decision Date	05/18/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review