FDA 510(k) Application Details - K153416

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K153416
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	ARCSCAN, INC. 443 PARK POINT DR, SUITE 225 GOLDEN, CO 80401 US Other 510(k) Applications for this Company
Contact	Andy Levien 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	11/25/2015
Decision Date	02/02/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review