FDA 510(k) Application Details - K101868

Device Classification Name	More FDA Info for this Device
510(K) Number	K101868
Device Name	INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V
Applicant	TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR TUSTIN, CA 92780 US Other 510(k) Applications for this Company
Contact	PAUL BIGGINS 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	07/02/2010
Decision Date	09/07/2010
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