510(k) Premarket Notification

• Device Classification Name: System, Simulation, Radiation Therapy
• 510(k) Number: K853349
• Device Name: VARIAN XIMATRON C-SERIES RADIOTHERAPY TREATMENT ST
• Applicant: Varian Assoc., Inc.; 611 Hansen Way; P.O. Box 10800; Palo Alto, CA 94303
• Applicant Contact: MILTON D SIEGEL
• Correspondent: Varian Assoc., Inc.; 611 Hansen Way; P.O. Box 10800; Palo Alto, CA 94303
• Correspondent Contact: MILTON D SIEGEL
• Regulation Number: 892.5840
• Classification Product Code: KPQ
• Date Received: 08/12/1985
• Decision Date: 10/28/1985
• Decision: Substantially Equivalent (SESE)
• Regulation Medical Specialty: Radiology
• 510k Review Panel: Radiology
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH Recalls