FDA 510(k) Application Details - K182153

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K182153
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	Tsutomu Fukui 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	08/08/2018
Decision Date	09/06/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review