FDA 510(k) Application Details - K983660

Device Classification Name	System, Radiation Therapy, Charged-Particle, Medical   More FDA Info for this Device
510(K) Number	K983660
Device Name	System, Radiation Therapy, Charged-Particle, Medical
Applicant	BRAINLAB, INC. 3100 HANSEN WAY BUILDING 4A, MAILSTOP E233 PALO ALTO, CA 94304 US Other 510(k) Applications for this Company
Contact	ERIC LINDQUIST Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	LHN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/19/1998
Decision Date	07/14/1999
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