FDA 510(k) Application Details - K041027

Device Classification Name	System, X-Ray, Angiographic   More FDA Info for this Device
510(K) Number	K041027
Device Name	System, X-Ray, Angiographic
Applicant	TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DRIVE TUSTIN, CA 92780 US Other 510(k) Applications for this Company
Contact	MICHAELA MAHL Other 510(k) Applications for this Contact
Regulation Number	892.1600   More FDA Info for this Regulation Number
Classification Product Code	IZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/21/2004
Decision Date	05/14/2004
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