FDA 510(k) Application Details - K122241

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K122241
Device Name	System, Tomography, Computed, Emission
Applicant	CARDIOVASCULAR IMAGING TECHNOLOGIES 9755 RIDGE DRIVE LENEXA, KS 66219 US Other 510(k) Applications for this Company
Contact	MELANIE HASEK Other 510(k) Applications for this Contact
Regulation Number	892.1200   More FDA Info for this Regulation Number
Classification Product Code	KPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/2012
Decision Date	10/24/2012
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