510(k) Premarket Notification

• Device Classification Name: accelerator, linear, medical
• 510(K) Number: K121657
• Model: 30X40,100,180,250
• Device Name: PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-SHPING RANGE COMPENSATOR
• Applicant: PROTON SYSTEMS; 611 west 5th street; third floor; austin, TX 78701
• Contact: mike begala
• Regulation Number: 892.5050
• Classification Product Code: IYE
• Date Received: 06/05/2012
• Decision Date: 10/23/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Radiology
• Review Advisory Committee: Radiology
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No