FDA 510(k) Application Details - K982045

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K982045
Device Name	System, Tomography, Computed, Emission
Applicant	IS2 RESEARCH, INC. 20 GURDWARA RD., BAYS 3-6 NEPEAN, ONTARIO K2E 8B3 CA Other 510(k) Applications for this Company
Contact	PETER SCHULTZ 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	06/10/1998
Decision Date	09/02/1998
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