PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-SHPING RANGE COMPENSATOR

Accelerator, Linear, Medical

PROTON SYSTEMS

The following data is part of a premarket notification filed by Proton Systems with the FDA for Proton Radiation Therapy Beam-shaping Aperture Proton Radiaion Therapy Beam-shping Range Compensator.

Pre-market Notification Details

• Device ID: K121657
• 510k Number: K121657
• Device Name: PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-SHPING RANGE COMPENSATOR
• Classification: Accelerator, Linear, Medical
• Applicant: PROTON SYSTEMS 611 WEST 5TH STREET THIRD FLOOR Austin, TX 78701
• Contact: Mike Begala
• Correspondent: Mike Begala; PROTON SYSTEMS 611 WEST 5TH STREET THIRD FLOOR Austin, TX 78701
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-06-05
• Decision Date: 2012-10-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00861206000382	K121657	000
00861206000375	K121657	000
00861206000368	K121657	000
00861206000351	K121657	000
00861206000344	K121657	000
00861206000337	K121657	000