Other products from "RADIOMED CORP"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 B887PTTL050110210 PTTL-050-11021 PTTL-050-11021 Qty 2 - 0.5mm x 0.5cm Platinum VISICOILS With a 10mm spacer in 21g x 20cm Needle Qty 2 - 0.5mm x 0.5cm Platinum VISICOILS With a 10mm spacer in 21g x 20cm Needle2 - 0.50mm x 0.5cm VISICOIL MR separated by a 10mm spacer (Non-Stranded) loaded in an 21 gauge pre-waxed brachytherapy needle. KXK Source, Brachytherapy, Radionuclide 2 VISICOIL MR Twin Line
2 B887MRTLS075920180 MRTLS-075-92018 MRTLS-075-92018 Qty 2-0.75mm x 0.5cm Platinum VISICOILS 20mm spacer 18g x 20cm Needle Stranded2 Qty 2-0.75mm x 0.5cm Platinum VISICOILS 20mm spacer 18g x 20cm Needle Stranded2 - 0.75mm x 0.50cm VISICOIL MR separated by 20mm PGLA spacer (Stranded with PGLA Sleeve) loaded in an 18 gauge pre-waxed brachytherapy needle 20cm in length. KXK Source, Brachytherapy, Radionuclide 2 VISICOIL MR Twin Line
3 B887MRTLS075515180 MRTLS-075-51518 MRTLS-075-51518 Qty 2-0.75mm x 0.5cm Platinum VISICOILS 15mm spacer 18g x 20cm Needle2 - 0.75mm Qty 2-0.75mm x 0.5cm Platinum VISICOILS 15mm spacer 18g x 20cm Needle2 - 0.75mm x 0.50cm VISICOIL MR Platinum separated by a 15mm PGLA spacer (Stranded) loaded in an 18 gauge pre-waxed brachytherapy needle. KXK Source, Brachytherapy, Radionuclide 2 VISICOIL MR Twin Line
4 B887MRTLS050515200 MRTLS-050-51520 MRTLS-050-51520 Qty 2- 0.50mm x 0.5cm Platinum VISICOILS 15mm spacer 20g x 20cm Needle2 - 0.50mm Qty 2- 0.50mm x 0.5cm Platinum VISICOILS 15mm spacer 20g x 20cm Needle2 - 0.50mm x 0.5cm VISICOIL MR separated by a 15mm spacer (Stranded) loaded in an 20 gauge pre-waxed brachytherapy needle. KXK Source, Brachytherapy, Radionuclide 2 VISICOIL MR Twin Line
5 B887MRTL075820190 MRTL-075-82019 MRTL-075-82019 Qty 2-0.75mm x 0.5cm Platinum VISICOILS 15mm spacer 19g x 20cm Needle2 - 0.75mm Qty 2-0.75mm x 0.5cm Platinum VISICOILS 15mm spacer 19g x 20cm Needle2 - 0.75mm x 0.50cm VISICOIL MR separated by a 20mm PGLA spacer (Non-Stranded) loaded in an 19 gauge pre-waxed brachytherapy needle. KXK Source, Brachytherapy, Radionuclide 2 VISICOIL MR Twin Line
6 B887MRTL075415190 MRTL-075-41519 MRTL-075-41519 Qty 2-0.75mm x 0.5cm Platinum VISICOILS 15mm spacer 19g x 20cm Needle2 - 0.75mm Qty 2-0.75mm x 0.5cm Platinum VISICOILS 15mm spacer 19g x 20cm Needle2 - 0.75mm x 0.50cm VISICOIL MR Platinum separated by a 15mm PGLA spacer (Non-Stranded) loaded in an 19 gauge pre-waxed brachytherapy needle. KXK Source, Brachytherapy, Radionuclide 2 VISICOIL MR Twin Line
7 B887MRTL050820210 MRTL-050-82021 MRTL-050-82021 Qty 2-0.50mm x 0.5cm Platinum VISICOILS 20mm spacer 21g x 20cm Needle2 - 0.50mm Qty 2-0.50mm x 0.5cm Platinum VISICOILS 20mm spacer 21g x 20cm Needle2 - 0.50mm x 0.5cm VISICOIL MR separated by a 20mm spacer (Non-Stranded) loaded in an 21 gauge pre-waxed brachytherapy needle. KXK Source, Brachytherapy, Radionuclide 2 VISICOIL MR Twin Line
8 B887MRTL050415210 MRTL-050-41521 MRTL-050-41521 Qty 2-0.50mm x 0.5cm Platinum VISICOILS 15mm spacer 21g x 20cm Needle2 - 0.50mm Qty 2-0.50mm x 0.5cm Platinum VISICOILS 15mm spacer 21g x 20cm Needle2 - 0.50mm x 0.5cm VISICOIL MR separated by a 15mm spacer (Non-Stranded) loaded in an 21 gauge pre-waxed brachytherapy needle. KXK Source, Brachytherapy, Radionuclide 2 VISICOIL MR Twin Line
9 B887MRTL050415200 MRTL-050-41520 MRTL-050-41520 Qty 2- 0.50mm x 0.5cm Platinum VISICOILS 15mm spacer 20g x 20cm Needle2 - 0.50mm Qty 2- 0.50mm x 0.5cm Platinum VISICOILS 15mm spacer 20g x 20cm Needle2 - 0.50mm x 0.5cm VISICOIL MR separated by a 15mm spacer (Non-Stranded) loaded in an 20 gauge pre-waxed brachytherapy needle. KXK Source, Brachytherapy, Radionuclide 2 VISICOIL MR Twin Line
10 B887GF18230 GF1823 GF1823 3 Pack 1.0mm x 5mm Gold Fiducial Marker Pre-Loaded in a 18g x 20cm Needle. JAK,IYE System, X-Ray, Tomography, Computed,Accelerator, Linear, Medical 2 Gold Fiducial
11 B887GF15330 GF1533 GF1533 3 Pack 1.2mm x 5mm Gold Fiducial Marker Pre-Loaded in a 17g x 30cm Needle. JAK,IYE System, X-Ray, Tomography, Computed,Accelerator, Linear, Medical 2 Gold Fiducial
12 B887GF15310 GF1531 GF1531 1.2mm x 5mm Gold Fiducial Marker Pre-Loaded in a 17g x 30cm Needle. JAK,IYE System, X-Ray, Tomography, Computed,Accelerator, Linear, Medical 2 Gold Fiducial
13 B887GF15240 GF1524 GF1524 4 Pack 1.2mm x 5mm Gold Fiducial Marker Pre-Loaded in a 17g x 20cm Needle. JAK,IYE System, X-Ray, Tomography, Computed,Accelerator, Linear, Medical 2 Gold Fiducial
14 B887GF15230 GF1523 GF1523 3 Pack 1.2mm x 5mm Gold Fiducial Marker Pre-Loaded in a 17g x 20cm Needle. JAK,IYE System, X-Ray, Tomography, Computed,Accelerator, Linear, Medical 2 Gold Fiducial
15 B887GF15210 GF1521 GF1521 1.2mm x 5mm Gold Fiducial Marker Pre-Loaded in a 17g x 20cm Needle. JAK,IYE System, X-Ray, Tomography, Computed,Accelerator, Linear, Medical 2 Gold Fiducial
16 B887GF15033 GF1503 GF1503 3 Pack - 1.0mm x 5mm Gold Fiducial Marker Loose JAK,IYE System, X-Ray, Tomography, Computed,Accelerator, Linear, Medical 2 Gold Fiducial
17 B887GF15030 GF1503 GF1503 3 Pack - 1.0mm x 5mm Gold Fiducial Marker Loose JAK,IYE System, X-Ray, Tomography, Computed,Accelerator, Linear, Medical 2 Gold Fiducial
18 B887GF15010 GF1501 GF1501 1.0mm x 5mm Gold Fiducial Marker Loose JAK,IYE System, X-Ray, Tomography, Computed,Accelerator, Linear, Medical 2 Gold Fiducial
19 B887GF13340 GF1334 GF1334 4 Pack 1.2mm x 3mm Gold Fiducial Marker Pre-Loaded in a 17g x 30cm Needle. JAK,IYE System, X-Ray, Tomography, Computed,Accelerator, Linear, Medical 2 Gold Fiducial
20 B887GF13330 GF1333 GF1333 3 Pack 1.2mm x 3mm Gold Fiducial Marker Pre-Loaded in a 17g x 30cm Needle. JAK,IYE System, X-Ray, Tomography, Computed,Accelerator, Linear, Medical 2 Gold Fiducial
21 B887GF13310 GF1331 GF1331 1.2mm x 3mm Gold Fiducial Marker Pre-Loaded in a 17g x 30cm Needle. JAK,IYE System, X-Ray, Tomography, Computed,Accelerator, Linear, Medical 2 Gold Fiducial
22 B887GF13240 GF1324 GF1324 4 Pack - 1.0mm x 3mm Gold Fiducial Marker Pre-Loaded in a 18g x 20cm Needle. JAK,IYE System, X-Ray, Tomography, Computed,Accelerator, Linear, Medical 2 Gold Fiducial
23 B887GF13230 GF1323 GF1323 3 Pack - 1.0mm x 3mm Gold Fiducial Marker Pre-Loaded in a 18g x 20cm Needle. JAK,IYE System, X-Ray, Tomography, Computed,Accelerator, Linear, Medical 2 Gold Fiducial
24 B887GF10040 GF1004 GF1004 4 Pack - 1.2mm x 3mm Gold Fiducial Marker Pre-Loaded in a 17g x 20cm Needle. JAK System, X-Ray, Tomography, Computed 2 Gold Fiducial
25 B887GF10030 GF1003 GF1003 3 Pack - 1.2mm x 3mm Gold Fiducial Marker Pre-Loaded in a 17g x 20cm Needle. JAK,IYE System, X-Ray, Tomography, Computed,Accelerator, Linear, Medical 2 Gold Fiducial
26 B887GF03033 GF0303 GF0303 3 Pack, 0.8mm x 3mm Gold Fiducial Marker Loose JAK,IYE System, X-Ray, Tomography, Computed,Accelerator, Linear, Medical Gold Fiducial
27 B887GF03030 GF0303 GF0303 3 Pack, 0.8mm x 3mm Gold Fiducial Marker Loose JAK,IYE System, X-Ray, Tomography, Computed,Accelerator, Linear, Medical 2 Gold Fiducial
28 B887GF03020 GF0302 GF0302 0.8mm x 3mm Gold Fiducial Marker Loose JAK,IYE System, X-Ray, Tomography, Computed,Accelerator, Linear, Medical 2 Gold Fiducial
29 B88710790 1079 1079 0.85mm x 3cm X-MARK ULTRA Preloaded IYE Accelerator, Linear, Medical 2 X-Mark Ultra
30 B88710780 1078 1078 0.85mm x 2cm X-MARK ULTRA Preloaded in 18g Needle IYE Accelerator, Linear, Medical 2 X-Mark Ultra
31 B88710770 1077 1077 0.85mm x 1cm X-MARKTM ULTRA Preloaded IYE Accelerator, Linear, Medical 2 X-Mark Ultra
32 B88710720 1072 1072 0.85mm x 3cm X-MARK ULTRA Loose IYE Accelerator, Linear, Medical 2 X-Mark Ultra
33 B88710710 1071 1071 0.85mm x 2cm X-MARK ULTRA Loose IYE Accelerator, Linear, Medical 2 X-Mark Ultra
34 B88710700 1070 1070 0.85mm x 1cm X-MARK ULTRA Loose IYE Accelerator, Linear, Medical 2 X-Mark Ultra
35 B88710690 1069 1069 1.15mm x 3cm X-MARK ULTRA Preloaded IYE Accelerator, Linear, Medical 2 X-Mark Ultra
36 B88710680 1068 1068 1.15mm x 2cm X-MARK ULTRA Preloaded in 17g needle IYE Accelerator, Linear, Medical 2 X-Mark Ultra
37 B88710670 1067 1067 1.15mm x 1cm X-MARK ULTRA Preloaded IYE Accelerator, Linear, Medical 2 X-Mark Ultra
38 B88710620 1062 1062 1.15mm x 3cm X-MARK ULTRA Loose IYE Accelerator, Linear, Medical 2 X-Mark Ultra
39 B88710610 1061 1061 1.15mm x 2cm X-MARK ULTRA Loose IYE Accelerator, Linear, Medical 2 X-Mark Ultra
40 B88710600 1060 1060 1.15mm x 1cm X-MARK ULTRA Loose IYE Accelerator, Linear, Medical 2 X-Mark Ultra
41 B8870010470 001047 001047 0.45mm x 1cm X-MARK Preloaded (18G) IYE Accelerator, Linear, Medical 2 X-MARK
42 B8870010420 001042 001042 0.45mm x 3cm X-MARK Loose IYE Accelerator, Linear, Medical 2 X-MARK
43 B8870010410 001041 001041 0.45mm x 2cm X-MARK Loose IYE Accelerator, Linear, Medical 2 X-MARK
44 B8870010400 001040 001040 0.45mm x 1cm X-MARK Loose IYE Accelerator, Linear, Medical 2 X-MARK
45 B8870010290 001029 001029 0.85mm x 3cm X-MARK Preloaded IYE Accelerator, Linear, Medical 2 X-MARK
46 B8870010280 001028 001028 0.85mm x 2cm X-MARK Preloaded in 18g Needle IYE Accelerator, Linear, Medical 2 X-MARK
47 B8870010270 001027 001027 0.85mm x 1cm X-MARK Preloaded in 18g Needle IYE Accelerator, Linear, Medical 2 X-MARK
48 B8870010230 001023 001023 0.85mm x 3cm X-MARK Loose IYE Accelerator, Linear, Medical 2 X-MARK
49 B8870010220 001022 001022 0.85mm x 2cm X-MARK Loose IYE Accelerator, Linear, Medical 2 X-MARK
50 B8870010210 001021 001021 0.85mm x 1cm X-MARK Loose IYE Accelerator, Linear, Medical 2 X-MARK
Other products with the same Product Codes "JAK, IYE"
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 09120105730464 V2.11 The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric meas The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features of osteoarthritis (OA) on posterior-anterior or anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices. KOALA IB LAB GMBH
39 09120105730037 V2.05 The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric meas The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features of osteoarthritis (OA) on posterior-anterior or anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices. KOALA IB LAB GMBH
40 09120074399990 999 TEST TEST TEST IT-V MEDIZINTECHNIK GMBH
41 09120074398528 P10107-852 System M STEP IT-V MEDIZINTECHNIK GMBH
42 09120074398511 P10107-851 M STEP Base Patient Positioning Package IT-V MEDIZINTECHNIK GMBH
43 09120074398504 P10107-850 System M STEP IT-V MEDIZINTECHNIK GMBH
44 09120074398115 P10107-811 Knee Support Cushion IT-V MEDIZINTECHNIK GMBH
45 09120074397996 P10107-799 System ProSTEP Short PC MR low IT-V MEDIZINTECHNIK GMBH
46 09120074397989 P10107-798 System ProSTEP Mask IT-V MEDIZINTECHNIK GMBH
47 09120074397972 P10107-797 System ProSTEP Short PC MR IT-V MEDIZINTECHNIK GMBH
48 09120074397965 P10107-796 System ProSTEP Short Carbon IT-V MEDIZINTECHNIK GMBH
49 09120074397941 P10107-794 System ProSTEP PC MR low IT-V MEDIZINTECHNIK GMBH
50 09120074397934 P10107-793 System HeadSTEP Bite MR IT-V MEDIZINTECHNIK GMBH