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510(k) Premarket Notification Database

Device Classification Name:	SYSTEM, PLANNING, RADIATION THERAPY TREATMENT
Regulation Number:	892.5050 [See Other Products with this regulation number]
510(k) Number:	K032345
Device Name:	CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY
Applicant:	ACCURAY, INC. 570 DEL REY AVE. SUNNYVALE, CA 94085
Contact:	ANNE SCHLAGENHAFT
Product Code:	MUJ [See Other Manufacturers that make this Product]
Date Received:	08-04-2003
Decision Date:	09-03-2003
Decision:	SE
Advisory Committee:	RA
Statement/Summary/Purged Status:	Summary
Type:	Special
Review by Third Party:	N
Expedited Review:	N

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