FDA 510(k) Application Details - K964265

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K964265
Device Name	System, Tomography, Computed, Emission
Applicant	TRIONIX RESEARCH LABORATORY, INC. 8037 BAVARIA RD. TWINSBURG, OH 44087 US Other 510(k) Applications for this Company
Contact	DAPHNE REED 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	10/24/1996
Decision Date	11/12/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review