FDA 510(k) Application Details - K151060

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K151060
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	KONICA MINOLTA, INC. 1 SAKURA-MACHI HINO-SHI 191-8511 JP Other 510(k) Applications for this Company
Contact	Shigeyuki Kojima Other 510(k) Applications for this Contact
Regulation Number	892.1560   More FDA Info for this Regulation Number
Classification Product Code	IYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/2015
Decision Date	06/05/2015
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