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510(k) Data Aggregation
K Number
K172848Device Name
MEVION S250i Proton Beam Radiation Therapy Device
Manufacturer
Mevion Medical Systems
Date Cleared
2017-12-27
(99 days)
Product Code
LHN
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
Mevion Medical Systems
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MEVION S250i is intended to deliver proton radiation therapy treatment to patients with localized tumors or other conditions susceptible to treatment by radiation.
Device Description
The MEVION S250i is a proton beam radiation therapy system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose and dose distribution to the prescribed patient treatment site. The MEVON S250i is a modern proton therapy system combining a patented, gantry-mounted proton source and a precision scanning beamline with a highly integrated, image-based workflow. The proton accelerator is a superconducting synchrocyclotron. The synchrocyclotron source generates protons of energy 230 MeV and is mounted in a high-precision concentric gantry system that rotates and points at treatment isocenter at all times. The system components include a Beam Generation System, Beam Delivery System, Structural Support and Alignment System, Patient Positioning System, Control System Software, and a Hard-wired Safety System (HSS).
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K Number
K120676Device Name
S-250 PROTON BEAM RADIATION THERAPY SYSTEM
Manufacturer
MEVION MEDICAL SYSTEMS
Date Cleared
2012-06-04
(91 days)
Product Code
LHN
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
MEVION MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The S-250 is intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation.
The S-250 is a medical device indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.
Device Description
The S-250 is a low cost, one-room integrated device designed to administer proton radiation treatments to patients through delivery of a predetermined radiation dose to a pre-determined three dimensional treatment target volume in a manner that protects the patient, and hospital staff, from unnecessary exposure to radiation and other hazards.
The S-250 design requires a very compact proton accelerator which is supported on a rotating gantry such that a proton treatment beam can be directed toward the rotational center of the gantry over a range of about 180 degrees (straight up to straight down). The gantry holds the cyclotron at a large enough distance from the rotating arm(s) that a full treatment room floor can be extended around the treatment center and a treatment couch can support a patient over a large rotational (couch) range at isocenter.
The system will be a completely integrated system incorporating all functionality necessary to efficiently treat patients with proton beams. As such it incorporates near real time radiographic based patient alignment and coupled patient support devices (couch) with broad flexibility for supporting the patient relative to the treatment beam. The couch is capable of six-degree-of-freedom adjustment and be able to rotate about a vertical axis in a range of about 270 degrees, so as to provide full coverage of beam directions typically used in radiation therapy
To keep high precision of alignment of the field specific device (range compensator and apertures) to the patient, these devices will be supported on a separate gantry, close to the treatment center and not physically connected to the large gantry supporting the cyclotron. This will lighten the aiming requirements for the large gantry.
The S-250 is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose and dose distribution to the prescribed patient treatment site as provided by a separately marketed Treatment Planning System (TPS) not distributed by Mevion Medical Systems. The S-250™ is comprised of two main components. One is a beam delivery system whose primary responsibility is to ensure that the prescription parameters are properly delivered. The other is the beam generating system whose function is to generate the proton beam and direct it to the beam delivery system.
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