Other products from "ACCURAY INCORPORATED"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 M65810604640 1060464 NA Software, TomoApps, Version 5.1.2Operating Software for TomoTherapy systems (inc Software, TomoApps, Version 5.1.2Operating Software for TomoTherapy systems (including TomoH®, TomoHD®, TomoHDA) and Onrad Treatment System™ IYE,MUJ Accelerator, Linear, Medical,System, Planning, Radiation Therapy Treatment 2 NA
2 M65810602530 1060253 N/A Radixact Delivery System Software (Version 1.1) IYE Accelerator, Linear, Medical 2 Radixact™ Treatment Delivery System
3 M65810476410 1047641-000 NA CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM)The CyberKnife M6 Systems are computer-controlled medical systems for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy. They use a 6 MV linear accelerator mounted on a manipulator (robot) and a target locating subsystem to accurately deliver high-energy radiation (1000 MU/minute dose rate) to the treatment target. The target locating subsystem provides X-rays of the treatment area that lets the user know the position of the target.The CyberKnife M6 Systems use skull tracking, fiducial tracking (tracking of implanted radiographic markers), skeletal structure tracking, lung tumor tracking, Lung Optimized Treatment, and Synchrony Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The fixed, variable aperture and multileaf collimators are available as various beam-limiting secondary collimators. IYE Accelerator, Linear, Medical 2 CyberKnife® M6™ Systems
4 M65810598110 1059811 NA Software, Version 1.1.1, Accuray Precision Treatment Planning SystemThe Accuray Software, Version 1.1.1, Accuray Precision Treatment Planning SystemThe Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems. IYE,MUJ Accelerator, Linear, Medical,System,Planning,Radiation Therapy Treatment 2 Accuray Precision® Treatment Planning System
5 M65810577270 1057727 NA Software, Version 1.0.0.4, Treatment Delivery Console, Radixact(Operating Softwa Software, Version 1.0.0.4, Treatment Delivery Console, Radixact(Operating Software for Radixact Treatment Delivery System) IYE Accelerator, Linear, Medical 2 Radixact®, Treatment Delivery Console (TDC)
6 M65810573750 1057375 NA Software, Delivery Analysis, Version 1.2 IYE,MUJ Accelerator, Linear, Medical,System,Planning,Radiation Therapy Treatment 2 Delivery Analysis TM
7 M65810565930 1056593 NA Software, Version 1.0.0.3, Treatment Delivery Console (TDC), Radixact(Operating Software, Version 1.0.0.3, Treatment Delivery Console (TDC), Radixact(Operating Software for Radixact® Treatment Delivery System) IYE Accelerator, Linear, Medical 2 Radixact®, Treatment Delivery Console (TDC)
8 M65810550960 1055096 NA Software, Version 1.0.0.1, Accuray Precision Treatment Planning System, The Accu Software, Version 1.0.0.1, Accuray Precision Treatment Planning System, The Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems. MUJ System,Planning,Radiation Therapy Treatment 2 Accuray Precision® Treatment Planning System
9 M65810525910 1052591 NA Software, Delivery Analysis, Version 1.1 MUJ,IYE System,Planning,Radiation Therapy Treatment,Accelerator, Linear, Medical 2 Delivery Analysis TM
10 M65810502420 1050242 NA Software, Version 1.0, Precision Treatment Planning SystemThe Accuray Precision Software, Version 1.0, Precision Treatment Planning SystemThe Accuray Precision Treatment Planning System is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery. MUJ System,Planning,Radiation Therapy Treatment 2 Accuray Precision® Treatment Planning System
11 M65810502410 1050241 NA Software, Version 1.0.0.1, Treatment Delivery Console (TDC), Radixact(Operating Software, Version 1.0.0.1, Treatment Delivery Console (TDC), Radixact(Operating Software for Radixact® Treatment Delivery System) IYE Accelerator, Linear, Medical 2 Radixact®, Treatment Delivery Console (TDC)
12 M65810642700 1064270 NA Software, Version 2.0, Accuray Precision Treatment Planning SystemThe Accuray Pr Software, Version 2.0, Accuray Precision Treatment Planning SystemThe Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems. MUJ System, Planning, Radiation Therapy Treatment 2 Accuray Precision® Treatment Planning System
13 M65810624240 1062424 NA Software, TomoApps, Version 5.1.3Operating Software for TomoTherapy systems (inc Software, TomoApps, Version 5.1.3Operating Software for TomoTherapy systems (including TomoH, TomoHD, TomoHDA) and Onrad Treatment System. IYE,MUJ Accelerator, Linear, Medical,System, Planning, Radiation Therapy Treatment 2 NA
14 M65810617990 1061799 NA Software, Accuray Precision Treatment Planning System, (Version 1.1.1.1)The Accu Software, Accuray Precision Treatment Planning System, (Version 1.1.1.1)The Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems. MUJ,IYE System,Planning,Radiation Therapy Treatment,Accelerator, Linear, Medical 2 Accuray Precision® Treatment Planning System
15 M6580330000 033000-000 NA The CyberKnife VSI System is a computer controlled medical systems for planning The CyberKnife VSI System is a computer controlled medical systems for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy using a treatment radiation generator, linear accelerator, manipulator (robot), and a target locating subsystem to accurately deliver radiation to the treatment target. The target locating system provides X-rays of the treatment area taken by a diagnostic X-ray system that lets the user know the position of the target. The CyberKnife VSI Systems use skull tracking, fiducial tracking, Xsight® Spine Tracking, Xsight® Lung Tracking, and Synchrony® Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The system uses a 6 MV linear accelerator to provide a dose rate up to 1000 MU/minute. IYE Accelerator, Linear, Medical 2 CyberKnife VSI® System
16 M65810182840 1018284-000 NA TomoTherapy® Treatment System (H Series) IYE,MUJ Accelerator, Linear, Medical,System,Planning,Radiation Therapy Treatment 2 TomoH® Treatment Delivery System
17 M65810600000 1060000 NA The Radixact Treatment Delivery System is a radiation therapy delivery system th The Radixact Treatment Delivery System is a radiation therapy delivery system that provides Image Guided Radiation Therapy (IGRT) using integral megavoltage CTimaging capabilities and delivers helical (rotational) and fixed-angle (non-rotational) radiation therapy to tumors and other targeted tissues.The Radixact Treatment Delivery System is a prescription device that delivers radiation in accordance with a physician approved plan. The Radixact Treatment Delivery System does not diagnose disease, recommend treatment regimens or quantify treatment effectiveness. It is not intended for diagnostic use. IYE Accelerator, Linear, Medical 2 Radixact® Treatment Delivery System
18 M6581055810 1055810 NA Software, Version 11.0, CyberKnife(Operating Software group for CyberKnife Treat Software, Version 11.0, CyberKnife(Operating Software group for CyberKnife Treatment Delivery System) IYE Accelerator, Linear, Medical 2 CyberKnife® Treatment Delivery System
19 M65810492110 1049211 NA The Onrad™ Treatment System is a radiation therapy system that integrates planni The Onrad™ Treatment System is a radiation therapy system that integrates planning, dosecalculation, megavoltage CT imaging for IGRT functionality, and fixed beam (non-rotational)radiation therapy treatment capabilities into a single comprehensive system.The Onrad™ Treatment System is a prescription device. It delivers radiation in accordancewith a physician approved plan. The device does not diagnose disease, recommend treatmentregimens, or quantify treatment effectiveness. The megavoltage CT imaging functionality isnot intended for diagnostic use. MUJ System, Planning, Radiation Therapy Treatment 2 Onrad Treatment System
20 00811376030023 1061945 NA Software, CyberKnife Version 11.1 (Software group that operates CyberKnife Treat Software, CyberKnife Version 11.1 (Software group that operates CyberKnife Treatment Delivery System) IYE Accelerator, Linear, Medical 2 CyberKnife® Treatment Delivery System
21 M65806600000 0660000 NA The CyberKnife® Treatment Delivery System (CKTDS) is a computer-controlled radia The CyberKnife® Treatment Delivery System (CKTDS) is a computer-controlled radiation treatment delivery system for performing minimally invasive stereotactic radiosurgery and precision radiotherapy. The CyberKnife Treatment Delivery System is intended to work with Accuray Precision® Treatment Planning System and iDMS™ Data Management System. IYE Accelerator, Linear, Medical 2 CyberKnife® Treatment Delivery System
22 M65810682840 1068284 NA The TomoTherapy Treatment Delivery System with iDMS is indicated for the deliver The TomoTherapy Treatment Delivery System with iDMS is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner. IYE Accelerator, Linear, Medical 2 TomoTherapy Treatment Delivery System with iDMS
23 M65810682860 1068286 NA The TomoTherapy Treatment Delivery System with iDMS is indicated for the deliver The TomoTherapy Treatment Delivery System with iDMS is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner. IYE Accelerator, Linear, Medical 2 TomoTherapy Treatment Delivery System with iDMS
24 M65810682830 1068283 NA The TomoTherapy Treatment Delivery System with iDMS is indicated for the deliver The TomoTherapy Treatment Delivery System with iDMS is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner. IYE Accelerator, Linear, Medical 2 TomoTherapy Treatment Delivery System with iDMS
25 M65810620710 1062071 NA TomoTherapy Treatment Delivery System with iDMS, Version 1.1 IYE Accelerator, Linear, Medical 2 TomoTherapy Treatment Delivery System with iDMS
26 M65810643150 1064315 NA Software, Delivery Analysis, Version 1.2.2 IYE Accelerator, Linear, Medical 2 Delivery Analysis
27 M65810622130 1062213 NA Software, Delivery Analysis, Version 1.2.1 MUJ,IYE System, Planning, Radiation Therapy Treatment,Accelerator, Linear, Medical 2 Delivery Analysis
28 M6581043090 H-0000-0003 NA TomoTherapy Treatment System (Tomo HD™) IYE Accelerator, Linear, Medical 2 TomoTherapy Treatment System (Tomo HD™)
29 M65810466130 H-0000-0003 NA TomoTherapy Treatment System (re-new system) IYE Accelerator, Linear, Medical 2 reNEW™ Certified Pre-Owned System
30 M6580325000 032500-M-000 NA The CyberKnife VSI System is a computer controlled medical systems for planning The CyberKnife VSI System is a computer controlled medical systems for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy using a treatment radiation generator, linear accelerator, manipulator (robot), and a target locating subsystem to accurately deliver radiation to the treatment target. The target locating system provides X-rays of the treatment area taken by a diagnostic X-ray system that lets the user know the position of the target. The CyberKnife VSI Systems use skull tracking, fiducial tracking, Xsight® Spine Tracking, Xsight® Lung Tracking, and Synchrony® Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The system uses a 6 MV linear accelerator to provide a dose rate up to 1000 MU/minute. IYE Accelerator, Linear, Medical 2 CyberKnife® VSI™ System
31 M65810615130 1061513 NA Software, Version 2.0, iDMS Data Management SystemThe iDMS Data Management Syste Software, Version 2.0, iDMS Data Management SystemThe iDMS Data Management System is indicated for the storage, retrieval, and processing of data utilized in the practice of radiotherapy, stereotactic radiotherapy and stereotactic radiosurgery. IYE Accelerator, Linear, Medical 2 iDMS Data Management System
32 M65810489680 1048968 N/A Software, TomoApps, Version 2.1.1, Build # 5.1.1(Operating Software for TomoTher Software, TomoApps, Version 2.1.1, Build # 5.1.1(Operating Software for TomoTherapy systems, including TomoH®, TomoHD®, TomoHDA™ and Onrad™) IYE,MUJ Accelerator, Linear, Medical,System,Planning,Radiation Therapy Treatment 2 TomoTherapy® Treatment Delivery System
33 M65810572080 1057208 NA Software, Version 1.1, iDMS™ Data Management SystemThe iDMS™ Data Management Sys Software, Version 1.1, iDMS™ Data Management SystemThe iDMS™ Data Management System is indicated for the storage, retrieval, and processing of data utilized in the practice of radiotherapy, stereotactic radiotherapy and stereotactic radiosurgery. IYE Accelerator, Linear, Medical 2 iDMS™ Data Management System
34 M65810554870 1055487 NA Software, Version 1.0.0.2, Treatment Delivery Console, RadixactVersion 1.0.0.2(O Software, Version 1.0.0.2, Treatment Delivery Console, RadixactVersion 1.0.0.2(Operating Software for Radixact Treatment Delivery System) IYE Accelerator, Linear, Medical 2 Radixact®, Treatment Delivery Console
35 M65810498890 1049889 NA Software, Version 1.0, iDMS™ Data Management SystemThe iDMS™ Data Management Sys Software, Version 1.0, iDMS™ Data Management SystemThe iDMS™ Data Management System is indicated for the storage, retrieval, and processing of data utilized in the practice of radiotherapy, stereotactic radiotherapy and stereotactic radiosurgery. IYE Accelerator, Linear, Medical 2 iDMS™ Data Management System
36 00811376030085 1061514 NA IDMS Data Management System (Version 3.0) MUJ,IYE System, Planning, Radiation Therapy Treatment,Accelerator, Linear, Medical 2 iDMS Data Management System
37 M65810182830 1018283-000 NA TomoTherapy Treatment System (H Series) IYE,MUJ Accelerator, Linear, Medical,System,Planning,Radiation Therapy Treatment 2 TomoHD® Treatment Delivery System
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No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00850077007163 CC3-1000 Compu-cutter shielding bolck cutters cut foam block molds so that extremely prec Compu-cutter shielding bolck cutters cut foam block molds so that extremely precise alloy blocks can be made to shield patients during radiation treatment. Compu-Cutter 111 HUESTIS MACHINE CORPORATION
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6 00850011006115 3 ASM0195 The Calypso System utilizes non-ionizing electromagnetic and optical technology The Calypso System utilizes non-ionizing electromagnetic and optical technology to provide accurate, objective, and continuous localization of a treatment target for patient alignment and target position monitoring during radiation therapy. Use of the Calypso System for target localization is based on the system’s detection of electromagnetic signals from passive implanted markers, called Beacon transponders. The Beacon transponders are placed on the patient’s skin surface or implanted in or near the treatment target. When used with the Calypso System, the Beacon transponder signals enable objective, continuous measurement of the localization of the treatment target in 3 dimensions. The system operator uses this information for patient alignment and continuous target positioning (i.e., tracking) during radiation therapy treatment. Calypso System VARIAN MEDICAL SYSTEMS, INC.
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