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510(k) Data Aggregation
K Number
K121657Device Name
PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-SHPING RANGE COMPENSATOR
Manufacturer
PROTON SYSTEMS
Date Cleared
2012-10-23
(140 days)
Product Code
IYE, IXI
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
PROTON SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Proton Systems' proton radiation therapy beam-shaping aperture and range compensator manufacturing service manufactures the solid apertures and range compensators for intensity modulation of external beam proton radiation therapy. The apertures and range compensators are designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.
Device Description
Proton Systems manufactures radiation therapy beam-shaping apertures and range compensators to customer patient-specific specifications.
In proton therapy for cancer, a proton beam is aimed at the cancerous tissue using a large "snout". The snout is rotated around the patient using a large, three-story gantry. While the patient lies on a treatment table, the gantry rotates around and points the snout at predetermined positions to maximize efficiency and dose delivery to the tumor volume. Each gantry angle, or port, requires two custom-made, beam-modifying patient-specific devices: an aperture and a range compensator.
The aperture is inserted into the gantry's snout to shape and focus the proton beam as it exits the qantry en route to the targeted area. The aperture is made of brass 360 with a 2D pattern / hole cut out of it, which defines the area that is to be treated with the proton beam. The range compensator is made of acrylic or wax and controls the depth at which the proton beam energy is delivered. The custom shape and design for apertures and range compensators are generated out of the hospital's treatment planning software and are unique to each patient and each gantry angle (most patients will have two to three different gantry angles).
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