FDA 510(k) Application Details - K981027

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K981027
Device Name	System, Tomography, Computed, Emission
Applicant	CTI PET SYSTEMS, INC. 810 INNOVATION DR. P.O. BOX 22999 KNOXVILLE, TN 37932-2562 US Other 510(k) Applications for this Company
Contact	WILLIAM SKREMSKY 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	03/19/1998
Decision Date	06/08/1998
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