FDA 510(k) Application Details - K123508

Device Classification Name	More FDA Info for this Device
510(K) Number	K123508
Device Name	TRINIAS
Applicant	Shimadzu Corporation 1 Nishinokyo-Kuwabaracho Nakagyo-ku Kyoto 604-8511 JP Other 510(k) Applications for this Company
Contact	Toshio Kadowaki Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/2012
Decision Date	02/26/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review