FDA 510(k) Application Details - K121499

Device Classification Name	System, X-Ray, Tomographic   More FDA Info for this Device
510(K) Number	K121499
Device Name	System, X-Ray, Tomographic
Applicant	FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. STAMFORD, CT 06902-6300 US Other 510(k) Applications for this Company
Contact	KATHERINE Y CHOI Other 510(k) Applications for this Contact
Regulation Number	892.1740   More FDA Info for this Regulation Number
Classification Product Code	IZF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/21/2012
Decision Date	11/20/2012
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