No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 04056719002190 | P10603-111-223 | P10603-111 | iGUIDE® is the control software of the HexaPOD™ evo RT Couchtop. Software Reviso iGUIDE® is the control software of the HexaPOD™ evo RT Couchtop. Software Revison 2.2.3 includes security patch. | IYE | Accelerator, Linear, Medical | 2 | iGUIDE® |
2 | 04056719002244 | P10603-300 | P10603-300 | HexaPOD one Module is a robotic couch top which fine adjusts the tumour position HexaPOD one Module is a robotic couch top which fine adjusts the tumour position to the ISO center | JAI | Couch, Radiation Therapy, Powered | 2 | HexaPOD |
3 | 04056719001711 | P10603-142 | P10603-142 | HexaPOD™ evo PowerBox supplies the electrical power and interfaces between the components | JAI | Couch, Radiation Therapy, Powered | 2 | HexaPOD |
4 | 04056719001698 | P10603-100 | P10603-100 | HexaPOD™ evo Module is a robotic couch top which fine adjusts the tumour positio HexaPOD™ evo Module is a robotic couch top which fine adjusts the tumour position to the ISO center | JAI | Couch, Radiation Therapy, Powered | 2 | HexaPOD |
5 | 04056719001681 | P10602-132 | P10602-132 | HexaPOD™ Enable Switch Board enables the HexaPOD™ evo Module to execute a movement command | JAI | Couch, Radiation Therapy, Powered | 2 | HexaPOD |
6 | 04056719001667 | P10602-107 | P10602-107 | HexaPOD Handheld Controller for manual movement of HexaPOD evo module | JAI | Couch, Radiation Therapy, Powered | 2 | HexaPOD |
7 | 04056719002237 | P10105-183 | iBEAM evo CT Overlay RT is intended to support the patient during CT and PET CT iBEAM evo CT Overlay RT is intended to support the patient during CT and PET CT imaging procedures for radiation therapy applications. | IXQ | Table, radiographic, stationary top | 2 | iBEAM® | |
8 | 04056719002220 | P10105-182 | iBEAM®evo CT Overlay Siemens Biograph | IXQ | Table, radiographic, stationary top | 2 | iBEAM® | |
9 | 04056719002213 | P10105-300 | iBEAM® one Couchtop is intended to support the patient during radiation therapy iBEAM® one Couchtop is intended to support the patient during radiation therapy or radiation therapy simulation. | IXQ | Table, radiographic, stationary top | 2 | iBEAM® | |
10 | 04056719002084 | P10106-302 | The Fraxion™ Thermoplastic Mask Single Layer (10pcs) is affixed to the Fraxion H The Fraxion™ Thermoplastic Mask Single Layer (10pcs) is affixed to the Fraxion Headrest assuring safe immobilization and precise (re-) positioning. It is used in combination with the Fraxion Vacuum Cushion or Fraxion Vacuum Cushion Plus and the Fraxion Spacer. | IYE | Accelerator, Linear, Medical | Fraxion™ | ||
11 | 04056719002077 | P10106-301 | The Fraxion™ Thermoplastic Mask Nose (10pcs) is affixed to the Fraxion Headrest The Fraxion™ Thermoplastic Mask Nose (10pcs) is affixed to the Fraxion Headrest assuring safe immobilization and precise (re-) positioning. It is used in combination with the Fraxion Vacuum Cushion or Fraxion Vacuum Cushion Plus and the Fraxion Spacer. | IYE | Accelerator, Linear, Medical | Fraxion™ | ||
12 | 04056719001940 | P10102-233 | P10102-233 | BodyFIX® Manifold Cushion 500mm prevents the Cover Sheet from collapsing directl BodyFIX® Manifold Cushion 500mm prevents the Cover Sheet from collapsing directly against the vacuum tube by distributing the airflow around the patient. | IYE | Accelerator, Linear, Medical | 2 | BodyFIX |
13 | 04056719001933 | P10102-232 | P10102-232 | BodyFIX® Manifold Cushion 400mm prevents the Cover Sheet from collapsing directl BodyFIX® Manifold Cushion 400mm prevents the Cover Sheet from collapsing directly against the vacuum tube by distributing the airflow around the patient. | IYE | Accelerator, Linear, Medical | 2 | BodyFIX |
14 | 04056719001391 | P10106-104 | P10106-104 | The indexed FRAXION™ CT Adapter allows you to prepare patients for CT imaging. | IYE | Accelerator, Linear, Medical | 2 | Fraxion |
15 | 04056719001797 | P10106-324 | P10106-324 | The FRAXION™ Mouthpiece is affixed to the FRAXION™ Frontpiece assuring safe immo The FRAXION™ Mouthpiece is affixed to the FRAXION™ Frontpiece assuring safe immobilization and precise (re-) positioning. The mouthpiece is also fixed to the patient’s maxilla with a vacuum. | IYE | Accelerator, Linear, Medical | Fraxion | |
16 | 04056719001780 | P10106-323 | P10106-323 | The FRAXION™ Mouthpiece is affixed to the FRAXION™ Frontpiece assuring safe immo The FRAXION™ Mouthpiece is affixed to the FRAXION™ Frontpiece assuring safe immobilization and precise (re-) positioning. The mouthpiece is also fixed to the patient’s maxilla with a vacuum. | IYE | Accelerator, Linear, Medical | 2 | Fraxion |
17 | 04056719001773 | P10106-322 | P10106-322 | The FRAXION™ Mouthpiece is affixed to the FRAXION™ Frontpiece assuring safe immo The FRAXION™ Mouthpiece is affixed to the FRAXION™ Frontpiece assuring safe immobilization and precise (re-) positioning. The mouthpiece is also fixed to the patient’s maxilla with a vacuum. | IYE | Accelerator, Linear, Medical | 2 | Fraxion |
18 | 04056719001766 | P10106-321 | P10106-321 | The FRAXION™ Mouthpiece is affixed to the FRAXION™ Frontpiece assuring safe immo The FRAXION™ Mouthpiece is affixed to the FRAXION™ Frontpiece assuring safe immobilization and precise (re-) positioning. The mouthpiece is also fixed to the patient’s maxilla with a vacuum. | IYE | Accelerator, Linear, Medical | Fraxion | |
19 | 04056719001254 | P10105-252 | P10105-252 | Connexion™ Tennis Racket Inlay | IXQ | Table, Radiographic, Stationary Top | 2 | Connexion |
20 | 04056719001759 | P10106-320 | P10106-320 | The FRAXION™ Mouthpiece is affixed to the Fraxion Frontpiece assuring safe immob The FRAXION™ Mouthpiece is affixed to the Fraxion Frontpiece assuring safe immobilization and precise (re-) positioning. The mouthpiece is also fixed to the patient’s maxilla with a vacuum. | IYE | Accelerator, Linear, Medical | Fraxion | |
21 | 04056719001735 | P10102-309 | P10102-309 | BodyFIX® Hygienic Drape Manifold Cushion (2x15000mm) is used to cover the vacuum BodyFIX® Hygienic Drape Manifold Cushion (2x15000mm) is used to cover the vacuum manifold cushion for hygienic purposes. | IYE | Accelerator, Linear, Medical | 2 | BodyFIX |
22 | 04056719001728 | P10102-305 | P10102-305 | BodyFIX® Hygienic Drape Manifold Tube (2x15000mm) is used to cover the manifold BodyFIX® Hygienic Drape Manifold Tube (2x15000mm) is used to cover the manifold tube for hygienic purposes. | IYE | Accelerator, Linear, Medical | 2 | BodyFIX |
23 | 04056719001650 | P10106-603 | P10106-603 | The Fraxion FRAXION™ Preparation Kit includes individual patient storage boxes a The Fraxion FRAXION™ Preparation Kit includes individual patient storage boxes and all necessary components to prepare the individual patient set-up together with the FRAXION™ Mouthpiece Kit and the FRAXION™ Dental Kit. | IYE | Accelerator, Linear, Medical | 2 | Fraxion |
24 | 04056719001643 | P10106-602 | P10106-602 | "The Fraxion FRAXION™ Kit includes all necessary components to generate a patien "The Fraxion FRAXION™ Kit includes all necessary components to generate a patient-specific mouthpiece. It contains also the necessary Saliva Stop Patient which prevents salivafrom reaching the Patient Control Unit (sufficient for up to 20 patients)." | IYE | Accelerator, Linear, Medical | 2 | Fraxion |
25 | 04056719001636 | P10106-402 | P10106-402 | The FRAXION™ Headrest EC allows to treat patients from Leksell Gamma Knife® Perf The FRAXION™ Headrest EC allows to treat patients from Leksell Gamma Knife® Perfexion™ to Linac because of the identical geometry of the Headrests. | IYE | Accelerator, Linear, Medical | 2 | Fraxion |
26 | 04056719001575 | P10106-106 | P10106-106 | Fraxion™ Vacuum Pump provides vacuum to fix the Fraxion™ Mouthpiece and to evacu Fraxion™ Vacuum Pump provides vacuum to fix the Fraxion™ Mouthpiece and to evacuate the Fraxion™ Vacuum Cushion. | IYE | Accelerator, Linear, Medical | 2 | Fraxion |
27 | 04056719001568 | P10106-214 | P10106-214 | The FRAXION™ Vacuum cushions are formed to the patients head and enable highly a The FRAXION™ Vacuum cushions are formed to the patients head and enable highly accurate patient repositioning. Each cushion will be moulded individually for each patient and will be stored together with all patient-specific parts in the storage box for the whole treatment time. | IYE | Accelerator, Linear, Medical | 2 | Fraxion |
28 | 04056719001551 | P10106-213 | P10106-213 | The FRAXION™ Vacuum cushions are formed to the patients head and enable highly a The FRAXION™ Vacuum cushions are formed to the patients head and enable highly accurate patient repositioning. Each cushion will be moulded individually for each patient and will be stored together with all patient-specific parts in the storage box for the whole treatment time. | IYE | Accelerator, Linear, Medical | 2 | Fraxion |
29 | 04056719001544 | P10106-212 | P10106-212 | The FRAXION™ Vacuum cushions are formed to the patients head and enable highly a The FRAXION™ Vacuum cushions are formed to the patients head and enable highly accurate patient repositioning. Each cushion will be moulded individually for each patient and will be stored together with all patient-specific parts in the storage box for the whole treatment time. | IYE | Accelerator, Linear, Medical | 2 | Fraxion |
30 | 04056719001537 | P10106-211 | P10106-211 | The FRAXION™ Vacuum cushions are formed to the patients head and enable highly a The FRAXION™ Vacuum cushions are formed to the patients head and enable highly accurate patient repositioning. Each cushion will be moulded individually for each patient and will be stored together with all patient-specific parts in the storage box for the whole treatment time. | IYE | Accelerator, Linear, Medical | 2 | Fraxion |
31 | 04056719001520 | P10106-210 | P10106-210 | The FRAXION™ Vacuum cushions are formed to the patients head and enable highly a The FRAXION™ Vacuum cushions are formed to the patients head and enable highly accurate patient repositioning. Each cushion will be moulded individually for each patient and will be stored together with all patient-specific parts in the storage box for the whole treatment time. | IYE | Accelerator, Linear, Medical | 2 | Fraxion |
32 | 04056719001513 | P10106-200 | P10106-200 | The FRAXION™ Marking Sheets are used togethter with the FRAXION™ Stereotactic Fr The FRAXION™ Marking Sheets are used togethter with the FRAXION™ Stereotactic Frame in order to locate the treatment target in the coordinate system and position the patient. The marking sheets will be stored together with all patient-specific parts in the storage box for the whole treatment time. | IYE | Accelerator, Linear, Medical | Fraxion | |
33 | 04056719001506 | P10106-132 | P10106-132 | FRAXION™ is secured to the treatment table top by various tabletop adapter depen FRAXION™ is secured to the treatment table top by various tabletop adapter depending on treatment table. | IYE | Accelerator, Linear, Medical | 2 | Fraxion |
34 | 04056719001490 | P10106-131 | P10106-131 | FRAXION™ is secured to the treatment table top by various tabletop adapter depen FRAXION™ is secured to the treatment table top by various tabletop adapter depending on treatment table. | IYE | Accelerator, Linear, Medical | 2 | Fraxion |
35 | 04056719001483 | P10106-130 | P10106-130 | FRAXION™ is secured to the treatment table top by various tabletop adapter depen FRAXION™ is secured to the treatment table top by various tabletop adapter depending on treatment table. | IYE | Accelerator, Linear, Medical | 2 | Fraxion |
36 | 04056719001476 | P10106-123 | P10106-123 | FRAXION™ is secured to the treatment table top by various tabletop adapter depen FRAXION™ is secured to the treatment table top by various tabletop adapter depending on treatment table. | IYE | Accelerator, Linear, Medical | 2 | Fraxion |
37 | 04056719001469 | P10106-122 | P10106-122 | FRAXION™ is secured to the treatment table top by various tabletop adapter depen FRAXION™ is secured to the treatment table top by various tabletop adapter depending on treatment table. | IYE | Accelerator, Linear, Medical | 2 | Fraxion |
38 | 04056719001452 | P10106-120 | P10106-120 | FRAXION™ is secured to the treatment table top by various tabletop adapter depen FRAXION™ is secured to the treatment table top by various tabletop adapter depending on treatment table. | IYE | Accelerator, Linear, Medical | 2 | Fraxion |
39 | 04056719001445 | P10106-115 | P10106-115 | The protective covers are attached to the U-Frame and protect patients head duri The protective covers are attached to the U-Frame and protect patients head during setup. | IYE | Accelerator, Linear, Medical | 2 | Fraxion |
40 | 04056719001438 | P10106-114 | P10106-114 | The FRAXION™ Headrest ST is attached to the U-Frame to support the patient head. | IYE | Accelerator, Linear, Medical | 2 | Fraxion |
41 | 04056719001421 | P10106-113 | P10106-113 | Fraxion™ Spacer | IYE | Accelerator, Linear, Medical | 2 | Fraxion |
42 | 04056719001414 | P10106-111 | P10106-111 | The FRAXION™ Head Support Module ST is the main component of the system. It prov The FRAXION™ Head Support Module ST is the main component of the system. It provides the interface between patient immobilization components and the table top. | IYE | Accelerator, Linear, Medical | 2 | Fraxion |
43 | 04056719001407 | P10106-110 | P10106-110 | The FRAXION™ Head Support Module FX is the main component of the system. It prov The FRAXION™ Head Support Module FX is the main component of the system. It provides the interface between patient immobilization components and the table top. | IYE | Accelerator, Linear, Medical | 2 | Fraxion |
44 | 04056719001384 | P10106-103 | P10106-103 | "The FRAXION™ Stereotactic Frame is for target localization in stereotactic radi "The FRAXION™ Stereotactic Frame is for target localization in stereotactic radiation therapy and radiosurgery. The purpose of the stereotactic frame is to impose fiducials on images of the patient acquired during CT scanning. The fiducials are used for determining target coordinates and for slice alignment by treatment planningsoftware." | IYE | Accelerator, Linear, Medical | 2 | Fraxion |
45 | 04056719001377 | P10106-102 | P10106-102 | The FRAXION™ Patient Control Unit (PCU) provides the vacuum necessary for securi The FRAXION™ Patient Control Unit (PCU) provides the vacuum necessary for securing the mouthpiece to the patient’s maxilla, thus securely immobilizing the patient. It monitors the vacuum level to the mouthpiece and provides an alert when the mouthpiece becomes loosened. Additionally, the PCU is used for forming the vacuum cushion. | IYE | Accelerator, Linear, Medical | 2 | Fraxion |
46 | 04056719001278 | P10105-254 | P10105-254 | The Solid Inlay is required for the Connexion™ Central Opening Module. It provid The Solid Inlay is required for the Connexion™ Central Opening Module. It provides an area with low attenuation properties. | IXQ | Table, Radiographic, Stationary Top | 2 | Connexion |
47 | 04056719001261 | P10105-253 | P10105-253 | The Short Indexing bar is required for accurate repositioning of accessories at The Short Indexing bar is required for accurate repositioning of accessories at the middle area of the Connexion™ Lateral Opening Module. | IXQ | Table, Radiographic, Stationary Top | 2 | Connexion |
48 | 04056719001247 | P10105-251 | P10105-251 | The Indexing Bridges are required in order to use the BodyFIX® 14 Target Positio The Indexing Bridges are required in order to use the BodyFIX® 14 Target Positioner together with the Connexion™ Lateral Opening Module for SBRT. | IXQ | Table, Radiographic, Stationary Top | 2 | Connexion |
49 | 04056719001230 | P10105-250 | P10105-250 | The removable accessory rails are positioned along the superior lateral area of The removable accessory rails are positioned along the superior lateral area of the Connexion™ Imaging Module and the Connexion™ Central Opening Module. They are designed to be simply and easily removed between treatments. | IXQ | Table, Radiographic, Stationary Top | 2 | Connexion |
50 | 04056719001223 | P10105-213 | P10105-213 | Providing patient-specific immobilization for head and neck treatments often req Providing patient-specific immobilization for head and neck treatments often require a variety of immobilization devices. The Connexion™ Head and Neck Module provides a dedicated solution to support head and neck immobilization, by providing a common interface to not only Elekta immobilization devices, but also other commonly used third party accessories. | IXQ | Table, Radiographic, Stationary Top | 2 | Connexion |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 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. | TomoTherapy Treatment Delivery System with iDMS | ACCURAY INCORPORATED |
2 | 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. | TomoTherapy Treatment Delivery System with iDMS | ACCURAY INCORPORATED |
3 | 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. | TomoTherapy Treatment Delivery System with iDMS | ACCURAY INCORPORATED |
4 | M65810643150 | 1064315 | NA | Software, Delivery Analysis, Version 1.2.2 | Delivery Analysis | ACCURAY INCORPORATED |
5 | 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. | NA | ACCURAY INCORPORATED |
6 | M65810624090 | 1062409 | NA | Software, iDMS™ Data Management System, (Version 1.1.1.1)The iDMS™ Data Manageme Software, iDMS™ Data Management System, (Version 1.1.1.1)The 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. | iDMS™ Data Management System | ACCURAY INCORPORATED |
7 | M65810622130 | 1062213 | NA | Software, Delivery Analysis, Version 1.2.1 | Delivery Analysis | ACCURAY INCORPORATED |
8 | M65810620710 | 1062071 | NA | TomoTherapy Treatment Delivery System with iDMS, Version 1.1 | TomoTherapy Treatment Delivery System with iDMS | ACCURAY INCORPORATED |
9 | 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. | Accuray Precision® Treatment Planning System | ACCURAY INCORPORATED |
10 | 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. | iDMS Data Management System | ACCURAY INCORPORATED |
11 | 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™ | NA | ACCURAY INCORPORATED |
12 | M65810602530 | 1060253 | N/A | Radixact Delivery System Software (Version 1.1) | Radixact™ Treatment Delivery System | ACCURAY INCORPORATED |
13 | 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. | Radixact® Treatment Delivery System | ACCURAY INCORPORATED |
14 | 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. | Accuray Precision® Treatment Planning System | ACCURAY INCORPORATED |
15 | 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) | Radixact®, Treatment Delivery Console (TDC) | ACCURAY INCORPORATED |
16 | M65810573750 | 1057375 | NA | Software, Delivery Analysis, Version 1.2 | Delivery Analysis TM | ACCURAY INCORPORATED |
17 | 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. | iDMS™ Data Management System | ACCURAY INCORPORATED |
18 | 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) | Radixact®, Treatment Delivery Console (TDC) | ACCURAY INCORPORATED |
19 | 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) | CyberKnife® Treatment Delivery System | ACCURAY INCORPORATED |
20 | 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) | Radixact®, Treatment Delivery Console | ACCURAY INCORPORATED |
21 | M65810525910 | 1052591 | NA | Software, Delivery Analysis, Version 1.1 | Delivery Analysis TM | ACCURAY INCORPORATED |
22 | 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) | Radixact®, Treatment Delivery Console (TDC) | ACCURAY INCORPORATED |
23 | 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. | iDMS™ Data Management System | ACCURAY INCORPORATED |
24 | 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™) | TomoTherapy® Treatment Delivery System | ACCURAY INCORPORATED |
25 | 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. | CyberKnife® M6™ Systems | ACCURAY INCORPORATED |
26 | M65810466130 | H-0000-0003 | NA | TomoTherapy Treatment System (re-new system) | reNEW™ Certified Pre-Owned System | ACCURAY INCORPORATED |
27 | M6581043090 | H-0000-0003 | NA | TomoTherapy Treatment System (Tomo HD™) | TomoTherapy Treatment System (Tomo HD™) | ACCURAY INCORPORATED |
28 | M65810182860 | 1018286-000 | NA | TomoTherapy Treatment System (H Series) | TomoHDA® Treatment Delivery System | ACCURAY INCORPORATED |
29 | M65810182840 | 1018284-000 | NA | TomoTherapy® Treatment System (H Series) | TomoH® Treatment Delivery System | ACCURAY INCORPORATED |
30 | M65810182830 | 1018283-000 | NA | TomoTherapy Treatment System (H Series) | TomoHD® Treatment Delivery System | ACCURAY INCORPORATED |
31 | 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. | CyberKnife® Treatment Delivery System | ACCURAY INCORPORATED |
32 | M6580534010 | 053401-M-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. | CyberKnife® M6™ Systems | ACCURAY INCORPORATED |
33 | M6580533010 | 053301-M-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. | CyberKnife® M6™ Systems | ACCURAY INCORPORATED |
34 | M6580532010 | 053201-M-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. | CyberKnife® M6™ Systems | ACCURAY INCORPORATED |
35 | M6580531010 | 053101-M-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. | CyberKnife® M6™ Systems | ACCURAY INCORPORATED |
36 | 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. | CyberKnife VSI® System | ACCURAY INCORPORATED |
37 | 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. | CyberKnife® VSI™ System | ACCURAY INCORPORATED |
38 | 09120074399990 | 999 | TEST TEST TEST | IT-V MEDIZINTECHNIK GMBH | ||
39 | 09120074398528 | P10107-852 | System M STEP | IT-V MEDIZINTECHNIK GMBH | ||
40 | 09120074398511 | P10107-851 | M STEP Base Patient Positioning Package | IT-V MEDIZINTECHNIK GMBH | ||
41 | 09120074398504 | P10107-850 | System M STEP | IT-V MEDIZINTECHNIK GMBH | ||
42 | 09120074398115 | P10107-811 | Knee Support Cushion | IT-V MEDIZINTECHNIK GMBH | ||
43 | 09120074397996 | P10107-799 | System ProSTEP Short PC MR low | IT-V MEDIZINTECHNIK GMBH | ||
44 | 09120074397989 | P10107-798 | System ProSTEP Mask | IT-V MEDIZINTECHNIK GMBH | ||
45 | 09120074397972 | P10107-797 | System ProSTEP Short PC MR | IT-V MEDIZINTECHNIK GMBH | ||
46 | 09120074397965 | P10107-796 | System ProSTEP Short Carbon | IT-V MEDIZINTECHNIK GMBH | ||
47 | 09120074397941 | P10107-794 | System ProSTEP PC MR low | IT-V MEDIZINTECHNIK GMBH | ||
48 | 09120074397934 | P10107-793 | System HeadSTEP Bite MR | IT-V MEDIZINTECHNIK GMBH | ||
49 | 09120074397927 | P10107-792 | System FoamSTEP Plus | IT-V MEDIZINTECHNIK GMBH | ||
50 | 09120074397910 | P10107-791 | System HeadSTEP Bite Wide | IT-V MEDIZINTECHNIK GMBH |