FDA 510(k) Application Details - K133535

Device Classification Name	More FDA Info for this Device
510(K) Number	K133535
Device Name	INFX-8000V, V5.30
Applicant	TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DRIVE TUSTIN, CA 92780 US Other 510(k) Applications for this Company
Contact	CHARLEMAGNE CHUA Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/2013
Decision Date	07/23/2014
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