FDA 510(k) Application Details - K053086

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K053086
Device Name	System, Tomography, Computed, Emission
Applicant	MIE AMERICA, INC. 420 BENNETT RD. ELK GROVE VILLAGE, IL 60007 US Other 510(k) Applications for this Company
Contact	KAY WARREN 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	11/02/2005
Decision Date	01/27/2006
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