FDA 510(k) Application Details - K150342

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K150342
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	CARESTREAM HEALTH, INC. 150 VERONA STREET ROCHESTER, NY 14608 US Other 510(k) Applications for this Company
Contact	CAROLYN L WAGNER 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	02/11/2015
Decision Date	05/08/2015
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