FDA 510(k) Application Details - K981790

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K981790
Device Name	Accelerator, Linear, Medical
Applicant	ELEKTA ONCOLOGY SYSTEMS, LTD. 8 EXECUTIVE PARK WEST SUITE 809 ATLANTA, GA 30329 US Other 510(k) Applications for this Company
Contact	PAUL L SUMNER Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	IYE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/1998
Decision Date	08/07/1998
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