FDA 510(k) Application Details - K972816

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K972816
Device Name	Accelerator, Linear, Medical
Applicant	ADVANCED RADIATION THERAPY SYSTEMS, INC. 430 JEAN WAY KING OOF PRUSSIA, PA 19406 US Other 510(k) Applications for this Company
Contact	ALEXANDER C CHEUNG 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	07/29/1997
Decision Date	01/23/1998
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