FDA 510(k) Application Details - K142107

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K142107
Device Name	System, Image Processing, Radiological
Applicant	ECHO PIXEL INC. 2490 HOSPITAL DR. SUITE 310 MOUNTAIN VIEW, CA 94040 US Other 510(k) Applications for this Company
Contact	SERGIO AGUIRRE Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2014
Decision Date	01/21/2015
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	Y
Expedited Review