FDA 510(k) Application Details - K033955

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K033955
Device Name	System, Image Processing, Radiological
Applicant	MIRADA SOLUTIONS LTD. CTI MOLECULAR IMAGING, INC. 810 INNOVATION DRIVE KNOXVILLE, TN 37932 US Other 510(k) Applications for this Company
Contact	MARIA EBIO Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2003
Decision Date	03/17/2004
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	N
Expedited Review