FDA 510(k) Application Details - K143718

Device Classification Name	More FDA Info for this Device
510(K) Number	K143718
Device Name	Mammography Color Display DP-M3010
Applicant	CANON INC. 22-5, Tamura 9-chome Hiratsuka-shi 254-0013 JP Other 510(k) Applications for this Company
Contact	MASAKI TAMURA 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	12/29/2014
Decision Date	01/22/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review