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510(k) Data Aggregation
K Number
K160063Device Name
McLaren Proton Therapy System
Manufacturer
Date Cleared
2016-02-25
(43 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
McLaren Health Care Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The McLaren Proton Therapy System is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Device Description
The McLaren Proton Therapy System consists primarily of Beam Delivery and Beam Production systems. These systems are comprised of various components and/or accessories designed to produce and deliver a proton beam appropriate for patient treatment. The system components include:
- Beam Production System. This system produces the proton beam and directs it to the appropriate treatment room and is comprised of the following subsystems:
- Synchrotron subsystem. The accelerator unit is the source of the proton beam and is composed of the injector (which generates the proton beam) and the synchrotron (which accumulates, accelerates, and extracts the proton beam).
- Beam Transport subsystem. This subsystem guides the proton beam extracted from the synchrotron to the treatment room.
- Beam Delivery System. This system controls the irradiation dose and shapes the proton beam supplied through the beam transportation system into the configuration required for patient treatment, and directs the beam appropriately. It is comprised of the following subsystems:
- Scan/Dose subsystem
- Gantry subsystem
- Patient Positioning subsystem.
- Treatment Delivery Control subsystem
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