FDA 510(k) Application Details - K122109

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K122109
Device Name	System, X-Ray, Tomography, Computed
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	892.1750   More FDA Info for this Regulation Number
Classification Product Code	JAK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/17/2012
Decision Date	09/21/2012
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