classification System, Radiation Therapy, Charged-Particle, Medical Manufacturer:

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gudid Audio/Video MRI Patient comfort device Manufacturer: RESONANCE TECHNOLOGY, INC.

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gudid The PROBEAT-V 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, dose distribution and directed to the prescribed patient treatment site. Small Field Applicator is an optional accessory to the proton beam therapy system which can be added to the nozzle configuration of the cleared PROBEAT-V system to make the lateral penumbra sharp, as needed. The Small Field Applicator may be used in place of the optional removable Applicator having an aperture (collimator) that has been cleared as part of the PROBEAT-V system. Manufacturer: HITACHI HIGH-TECH CORPORATION

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gudid The PROBEAT-FR 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, dose distribution and directed to the prescribed patient treatment site. The PROBEAT-FR is a modification to the cleared PROBEAT-CR system, for installation at a different clinical site. Manufacturer: HITACHI, LTD.

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gudid The PROBEAT-CR 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, dose distribution and directed to the prescribed patient treatment site. The PROBEAT-CR is a modification to the cleared PROBEAT-V system, for installation at a different clinical site. Manufacturer: HITACHI, LTD.

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gudid The PROBEAT-V 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, dose distribution and directed to the prescribed patient treatment site. The Mini Ridge Filter is an optional accessory to modify the beam of the PROBEAT-V system. As auxiliary functions, a beam gating function and a fluoroscopy function during proton beam irradiation are added. Manufacturer: HITACHI, LTD.

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gudid The Real Time Image Gating System for Proton Beam Therapy Systems is intended for use with compatible Hitachi proton beam therapy systems and is designed to generate gating signals to deliver a proton beam when the position of a fiducial marker, which is implanted near a tumor and tracked by use of X-ray fluoroscopy, is within a given tolerance from its planned position. Manufacturer: HITACHI, LTD.

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gudid The PROBEAT-V with X-ray Limiting Accessory 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, dose distribution and directed to the prescribed patient treatment site. Manufacturer: HITACHI HIGH-TECH CORPORATION

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gudid The PROBEAT-V 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. The PROBEAT-V includes optional accessories to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. Manufacturer: HITACHI HIGH-TECH CORPORATION

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gudid The PROBEAT-V 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. Manufacturer: HITACHI HIGH-TECH CORPORATION

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gudid The Extended Range Shifter is an accessory to the PROBEAT-V system that is intended to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. Manufacturer: HITACHI HIGH-TECH CORPORATION

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gudid The PROBEAT with DSSS 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. The only difference between the PROBEAT with DSSS and the cleared PROBEAT is the addition of the Discrete Spot Scanning System ("DSSS"). Manufacturer: HITACHI HIGH-TECH CORPORATION

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gudid The PROBEAT with MGCS 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. The only difference between the PROBEAT with MGCS and the cleared PROBEAT is the addition of the MGCS that converts the scale and format of the dimensional data of the patient specific aperture and/or compensator generated by commercially available patient treatment planning/management software into the scale and format used by an industrial, computer controlled milling machine to enable the milling machine to fashion the required aperture or compensator for patient treabment. Manufacturer: HITACHI HIGH-TECH CORPORATION

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gudid The PROBEAT 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. Manufacturer: HITACHI HIGH-TECH CORPORATION

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gudid The PROBEAT-V 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, dose distribution and directed to the prescribed patient treatment site. Small Field Applicator is an optional accessory to the proton beam therapy system which can be added to the nozzle configuration of the cleared PROBEAT-V system to make the lateral penumbra sharp, as needed. The Small Field Applicator may be used in place of the optional removable Applicator having an aperture (collimator) that has been cleared as part of the PROBEAT-V system. Manufacturer: HITACHI, LTD.

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gudid Radiation therapy QA device. Manufacturer: SUN NUCLEAR CORP.

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gudid Radiation therapy QA device. Manufacturer: SUN NUCLEAR CORP.

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gudid Radiation therapy QA device. Manufacturer: SUN NUCLEAR CORP.

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gudid Radiation therapy QA device. Manufacturer: SUN NUCLEAR CORP.

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gudid Radiation therapy QA device. Manufacturer: SUN NUCLEAR CORP.

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gudid Radiation therapy QA device. Manufacturer: SUN NUCLEAR CORP.

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gudid Brainlab Elements SmartBrush Manufacturer: Brainlab SE

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gudid iPlan RT Image Manufacturer: Brainlab SE

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gudid SDX Trolley Manufacturer: DYN'R

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gudid Gating Module for IBA ProteusPlus Manufacturer: DYN'R

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gudid Gating Module for Varian C-Series Manufacturer: DYN'R

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gudid SDX Module Manufacturer: DYN'R

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gudid SDX Module Manufacturer: DYN'R

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gudid NA Manufacturer: ANZAI MEDICAL CO., LTD.

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gudid NA Manufacturer: ANZAI MEDICAL CO., LTD.

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gudid SDX Module: The SDX 3.0-SE (Special Edition) is new version of the SDX system 3.0 with a compact design: a standalone box housing all the necessary electronics, removing the need for the trolley.As the SDX system 3.0, The SDX system 3.0- Special Edition has the same intended use, the same technological characteristics , the same performances as that of the SDX system with automatic gating Module (primary predicate) and the SDX system 3.0. The SDX system 3.0-SE does not raise new questions of safety and effectiveness. Manufacturer: DYN'R

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gudid A physical slab of uniform low-density material placed in the path of a proton beam to intentionally degrade the energy of the beam, reducing the distance the protons travel so that they can effectively target shallow or superficial tumors. Manufacturer: McLaren Health Care Corporation

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gudid A physical slab of uniform low-density material placed in the path of a proton beam to intentionally degrade the energy of the beam, reducing the distance the protons travel so that they can effectively target shallow or superficial tumors. Manufacturer: McLaren Health Care Corporation

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gudid A physical slab of uniform low-density material placed in the path of a proton beam to intentionally degrade the energy of the beam, reducing the distance the protons travel so that they can effectively target shallow or superficial tumors. Manufacturer: McLaren Health Care Corporation

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gudid A physical slab of uniform low-density material placed in the path of a proton beam to intentionally degrade the energy of the beam, reducing the distance the protons travel so that they can effectively target shallow or superficial tumors. Manufacturer: McLaren Health Care Corporation

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gudid A physical slab of uniform low-density material placed in the path of a proton beam to intentionally degrade the energy of the beam, reducing the distance the protons travel so that they can effectively target shallow or superficial tumors. Manufacturer: McLaren Health Care Corporation

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gudid A physical slab of uniform low-density material placed in the path of a proton beam to intentionally degrade the energy of the beam, reducing the distance the protons travel so that they can effectively target shallow or superficial tumors. Manufacturer: McLaren Health Care Corporation

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gudid 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. Manufacturer: McLaren Health Care Corporation

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gudid GE GEM MR Cart Strain Relief for Zephyr & Mayfield Skull Clamp Manufacturer: Diacor, Inc.

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gudid GE GEM MR Cart Strain Relief for Zephyr & DORO Skull Clamp Manufacturer: Diacor, Inc.

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gudid Zephyr Docking Side Stop Bar - (1): Used on GE SIGNA PET/MR FTT for Zephyr Systems Manufacturer: Diacor, Inc.

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gudid Zephyr Docking Side Stop Bar - (1): Used on Philips Ingenia MR-SIM Manufacturer: Diacor, Inc.

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gudid Zephyr Docking Side Stop Bar - (1): Used on 50cm Non-Indexed Couch Manufacturer: Diacor, Inc.

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gudid Zephyr Docking Side Stop Bar - (1): Used on 53cm Elekta iBeam Couch Manufacturer: Diacor, Inc.

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gudid Zephyr Docking Side Stop Bar for 50cm XL - (1): Used on 53cm Varian Couch Manufacturer: Diacor, Inc.

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gudid Zephyr Docking Side Stop Bar - (1): Used on 53cm Varian Couch Manufacturer: Diacor, Inc.

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gudid Siemens DSA Table OTP Stops Manufacturer: Diacor, Inc.

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gudid OTP (Over-travel protection) solution kit for Hillrom/Trumpf Carbon Floatline Manufacturer: Diacor, Inc.

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gudid OTP (Over-travel protection) solution kit for Canon Angio Imaging Tables Manufacturer: Diacor, Inc.

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gudid OTP (Over-travel protection) solution kit for Trumpf Hybrid Carbon Fiber Table Top Manufacturer: Diacor, Inc.

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gudid OTP (Over-travel protection) solution kit for GE Omega or IQ Tilt Tables Manufacturer: Diacor, Inc.

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gudid OTP (Over-travel protection) solution kit for Maquet Magnus 1180 Imaging Table Manufacturer: Diacor, Inc.

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gudid OTP (Over-travel protection) solution kit for Philips AD7NT Imaging Table Manufacturer: Diacor, Inc.

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gudid Starpax Docking Kit for Zephyr Hoverboards Manufacturer: Diacor, Inc.

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gudid Zephyr Docking Kit for Philips Ingenia MR-SIM Includes (2) side stop bar and (1) foot end stop Manufacturer: Diacor, Inc.

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gudid Zephyr Docking Kit for Varian Exact Couch Indexing. Includes (1) side stop bar and (1) reversible foot end docking kit for MR couch Manufacturer: Diacor, Inc.

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gudid Zephyr Docking Kit 50cm for GE PET/MR Flat Table Top (FTT) Manufacturer: Diacor, Inc.

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gudid Zephyr Docking Kit 50cm Hitachi Treatment Couch: Includes (1) side stop bar and (1) reversible foot end docking plate Manufacturer: Diacor, Inc.

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gudid Zephyr Docking Kit ___cm Trumpf Imaging Couch Includes (1) side stop bar and (1) reversible foot end docking kit. Manufacturer: Diacor, Inc.

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gudid Zephyr Docking Kit 53cm for Elekta iBeam Couch Indexing. Includes (1) side stop bar and (1) reversible foot end docking kit. Manufacturer: Diacor, Inc.

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gudid Zephyr Docking Kit for 50cm XL on Varian. Includes (1) side stop bar and (1) reversible foot end docking kit. Manufacturer: Diacor, Inc.

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gudid Zephyr Docking Kit for Varian Exact Couch Indexing. Includes (1) side stop bar and (1) reversible foot end docking kit. Manufacturer: Diacor, Inc.

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gudid Zephyr Docking Kit for Varian Exact Couch Indexing and Zephyr IR 46cm Hoverboards. Includes (1) side stop bar and (1) reversible foot end docking kit.. Manufacturer: Diacor, Inc.

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gudid The X-ray Imaging System controls the x-ray generation, image processing and patient registration of the McLaren Proton Treatment System. The software product described by this document is considered a sub-system of the MPTS.The software product integrates with the following components of the MPTS system:X-ray generator & tube assemblyAmorphous silicon flat-panel detectorElectro-mechanical controls of the imaging c-ring to enable system positioning and rotation around the patientThe software will permit a radiation technician to set the desired energy levels and field of view. Once set the software can acquire orthogonal or CBCT x-ray images of the region of interest. When images are acquired the software will process them to create viewable images for patient location registration. The patient location registration workflow will locate the treatment isocenter, defined in the patient anatomy, relative to the desired position in the treatment room through which the beam passes. The location of the treatment isocenter is established during treatment planning with 3D planning images (CT simulation images). The patients position will be adjusted, if needed, based on a comparison of the current patient location, the defined treatment plan, and previously acquired Digitally Reconstructed Radiographs or CTs.There are two defined methods of registration,1.Digitally Reconstructed Radiographs (DRRs) from 3D planning images are compared to the 2D images taken during patient setup in order to compare the patient anatomy with the expected location and orientation given by the DRRs. The registration tool is implemented to display both the downloaded DRRs, provided by the treatment planning system, and the display of the new 2D images, acquired by x-ray imaging system.2.3D planned volume images are compared to the CBCT volumetric (CTs) images taken during patient setup in order to compare the patient anatomy with the expected location and orientation. The regis Manufacturer: EhmetDx LLC

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gudid The MEVION S250-FIT is intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation. When the patient is in the fully seated position, the MEVION S250-FIT is indicated for treatment of patients with localized tumors and other conditions susceptible to treatment by radiation in the sites above the mid-chest or carina.This configuration includes an optional subsystem for 2D image verification using oblique x-rays to verify patient alignment prior to beam delivery. Manufacturer: MEVION MEDICAL SYSTEMS, INC.

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gudid MEVION S250i Manufacturer: MEVION MEDICAL SYSTEMS, INC.

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gudid he MEVION S250-FIT Proton Beam Radiation Therapy Device is intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation. When the patient is in the fully seated position, the MEVION S250-FIT is indicated for treatment of patients with localized tumors and other conditions susceptible to treatment by radiation in the sites above the mid-chest or carina. Manufacturer: MEVION MEDICAL SYSTEMS, INC.

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gudid Proton Beam Radiation Therapy System Manufacturer: MEVION MEDICAL SYSTEMS, INC.

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gudid Proton Therapy System Manufacturer: PRONOVA SOLUTIONS, LLC

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gudid Proton Therapy System Manufacturer: PRONOVA SOLUTIONS, LLC

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gudid Radiance 330 Proton Therapy System Manufacturer: PROTOM INTERNATIONAL HOLDING CORPORATION

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gudid The MOBETRON is intended for use as an Electron Beam source inside an Operating Room for Electron Beam IORT. Electron beam IORT (Intra-Operative Radiation Therapy) is the use of electron radiation during surgery to treat both malignant and benign tumors. The Mobetron is not intended for unrestricted beam production. Extensive beam testing should be done in a stray radiation shielded room or a strictly controlled area. MOBETRON S/N: 72 Manufacturer: INTRAOP MEDICAL CORPORATION

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gudid MUCheck Independent Dose Calculation Software. MUCheck Software. MUCheck Software Suite. Oncology Data Systems, Inc. Manufacturer: Oncology Data Systems Inc

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gudid ProBeam 360 Proton Therapy System - Rotating Gantry Manufacturer: Varian Medical Systems Particle Therapy GmbH & Co. KG

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gudid ProBeam Proton Therapy System - Fixed Beam Room Manufacturer: Varian Medical Systems Particle Therapy GmbH & Co. KG

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gudid ProBeam Proton Therapy System - Rotating Gantry Manufacturer: Varian Medical Systems Particle Therapy GmbH & Co. KG

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gudid ProBeam 360 Proton Therapy System - Rotating Gantry Manufacturer: Varian Medical Systems Particle Therapy GmbH & Co. KG

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gudid ProBeam 360 Proton Therapy System - Rotaiting Gantry Manufacturer: Varian Medical Systems Particle Therapy GmbH & Co. KG

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gudid ProBeam Proton Therapy System - Fixed Beam Room Manufacturer: Varian Medical Systems Particle Therapy GmbH & Co. KG

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gudid ProBeam Proton Therapy System - Rotating Gantry Manufacturer: Varian Medical Systems Particle Therapy GmbH & Co. KG

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gudid ProBeam Rotating Gantry Proton Therapy System Manufacturer: Varian Medical Systems Particle Therapy GmbH & Co. KG

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gudid Rotating Gantry Manufacturer: Varian Medical Systems Particle Therapy GmbH & Co. KG

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gudid Fixed Beam Manufacturer: Varian Medical Systems Particle Therapy GmbH & Co. KG

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gudid Rotating Gantry Manufacturer: Varian Medical Systems Particle Therapy GmbH & Co. KG

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gudid Varian Verification Console Manufacturer: VARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED

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gudid Varian Verification Console Manufacturer: VARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED

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gudid PinPoint Manufacturer: PTW-Freiburg Physikalisch-Technische Werksttten Dr. Pychlau GmbH

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gudid Semiflex Manufacturer: PTW-Freiburg Physikalisch-Technische Werksttten Dr. Pychlau GmbH

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gudid PinPoint Manufacturer: PTW-Freiburg Physikalisch-Technische Werksttten Dr. Pychlau GmbH

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