FDA 510(k) Application Details - K143537

Device Classification Name	System, X-Ray, Mobile   More FDA Info for this Device
510(K) Number	K143537
Device Name	System, X-Ray, Mobile
Applicant	HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK TWINSBURG, OH 44087 US Other 510(k) Applications for this Company
Contact	DOUG THISTLEWAITE Other 510(k) Applications for this Contact
Regulation Number	892.1720   More FDA Info for this Regulation Number
Classification Product Code	IZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2014
Decision Date	03/06/2015
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