| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 08717213034129 | 137279-00 | Applicator Mask Straps | JAQ | System, applicator, radionuclide, remote-controlled | NA | ||
| 2 | 08717213024120 | 137416P01-02 | Intravaginal Tube, Ti | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 3 | 08717213008915 | 084457-00 | Intrauterine Tube, angle 30° | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 4 | 08717213036581 | 080026P01-00 | microSelectron Adapter for 6F catheters | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 5 | 08717213032286 | 083058P01-00 | Trocar Needle Ø1.9 mm x 160 mm | JAQ | System, applicator, radionuclide, remote-controlled | NA | ||
| 6 | 08717213042162 | 085119P01-00 | Cap, Ø 30 mm | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 7 | 08717213042155 | 085118P01-00 | Cap, Ø 20 mm | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 8 | 08717213034556 | 189740-06 | Ovoid Tube 2 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 9 | 08717213034549 | 189740P01-06 | Ovoid Tube 2 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 10 | 08717213042148 | 085117P01-00 | Cap, Ø 10 mm | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 11 | 08717213056961 | 131055A02-07 | Oncentra Prostate Laptop Cart | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 12 | 08717213056954 | 131055A01-07 | Oncentra Prostate Laptop Cart | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 13 | 08717213056947 | 189714P01-03 | INSERTION TOOL | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | NA | |
| 14 | 08717213053717 | 170538-00 | Oncentra External Beam 4.5.3/Oncentra Brachy v4.6 | MUJ | System, planning, radiation therapy treatment | 2 | NA | |
| 15 | 08717213053700 | 170018-00 | Oncentra External Beam 4.5.3/Oncentra Brachy v4.6 | MUJ | System, planning, radiation therapy treatment | NA | ||
| 16 | 08717213053151 | 101003P01-07 | Intrauterine Tube CT/MR 15°, 40 mm | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 17 | 08717213053137 | 101002P01-07 | Vaginal Tube | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 18 | 08717213053113 | 101005P01-07 | Intrauterine Tube CT/MR 45°, 80 mm | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 19 | 08717213053069 | 101004P01-07 | Intrauterine Tube CT/MR 30°, 60 mm | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 20 | 08717213052895 | 130512P01-01 | Needle Template B&K 18 G for LDR | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 21 | 08717213052826 | 130512C-00 | Adjusting Ring | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 22 | 08717213052789 | 189367P01-01 | Flexible Implant Tube Cutter | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 23 | 08717213052758 | 170607-00 | Oncentra External Beam Oncentra Brachy v4.6.1 | MUJ | System, planning, radiation therapy treatment | 2 | NA | |
| 24 | 08717213052710 | 110957P01-01 | Fixation Clip | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Fletcher CT/MR Shielded Applicator | |
| 25 | 08717213052666 | 101160-03 | Threaded End | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 26 | 08717213052659 | 110958-00 | Clip Part 1 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Fletcher CT/MR Shielded Applicator | |
| 27 | 08717213052642 | 110959-00 | Clip Part 2 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Fletcher CT/MR Shielded Applicator | |
| 28 | 08717213052321 | 170537-08 | Oncentra External Beam/Oncentra Brachy v4.5.3 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 29 | 08717213052314 | 170003-28 | Oncentra External Beam/Oncentra Brachy v4.5.3 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 30 | 08717213052307 | 170537-06 | Oncentra External Beam/Oncentra Brachy v4.5.3 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 31 | 08717213052291 | 170003-27 | Oncentra External Beam/Oncentra Brachy v4.5.3 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 32 | 08717213052246 | 170537-06 | Oncentra External Beam/Oncentra Brachy v4.5.3 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 33 | 08717213052239 | 170003-25 | Oncentra External Beam/Oncentra Brachy v4.5.3 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 34 | 08717213051881 | 170537-05 | Oncentra External Beam/Oncentra Brachy v4.5.2 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 35 | 08717213051843 | 170003-24 | Oncentra External Beam/Oncentra Brachy v4.5.2 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 36 | 08717213051799 | 089013P02-00 | Obturator for 1.5mm Needle x 200mm | JAQ | System, applicator, radionuclide, remote-controlled | NA | ||
| 37 | 08717213051782 | 170537-04 | Oncentra External Beam/Oncentra Brachy v4.5.2 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 38 | 08717213051775 | 170003-23 | Oncentra External Beam/Oncentra Brachy v4.5.2 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 39 | 08717213034532 | 189735-06 | Ovoid Tube 1 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 40 | 08717213051584 | 083926P02-00 | Trocar Needle 1.5mm x 200mm | JAQ | System, applicator, radionuclide, remote-controlled | NA | ||
| 41 | 08717213051379 | 189731P01-01 | Screw Pin | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 42 | 08717213051362 | 189727P01-01 | Fixation Clip Screw | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 43 | 08717213051270 | 089701P01-00 | Leader Insertion Needle, 1.5 x 160 mm | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 44 | 08717213051263 | 089700P02-00 | Leader Insertion Needles, 1.5 x 120 mm | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 45 | 08717213051140 | 106990 | microSelectron Digital | JAQ | System, applicator, radionuclide, remote-controlled | 2 | microSelectron Digital | |
| 46 | 08717213050945 | 111683P01-01 | Flexitron Transfer Tube GYN SS (G5-3) | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 47 | 08717213050938 | 111009P01-03 | microSelectron Transfer Tube CT/MR GYN (3) | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 48 | 08717213050860 | 084050P01-02 | Ring Applicator Set, Additional Items | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 49 | 08717213050853 | 110669P01-00 | Ring CT/MR Applicator Set 4mm, Additional Items | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 50 | 08717213050846 | 101035P01-04 | Ring CT/MR Applicator Set, Additional Items | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 10381780252962 | XKNIFETK | XKnife Tool Kit | XKnife® | INTEGRA LIFESCIENCES CORPORATION | |
| 2 | 10381780252955 | XK503UPK | XKnife 5.0.3 Upgrade Kit | XKnife® | INTEGRA LIFESCIENCES CORPORATION | |
| 3 | 10381780252948 | XK5 | XKnife 5.0 Installation Kit | XKnife® | INTEGRA LIFESCIENCES CORPORATION | |
| 4 | 10381780252931 | RTLXCOMP | XKnife Linux RT Workstation | XKnife® | INTEGRA LIFESCIENCES CORPORATION | |
| 5 | 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. | Accuray Precision® Treatment Planning System | ACCURAY INCORPORATED |
| 6 | 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 |
| 7 | M65810622130 | 1062213 | NA | Software, Delivery Analysis, Version 1.2.1 | Delivery Analysis | ACCURAY INCORPORATED |
| 8 | 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 |
| 9 | 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 |
| 10 | 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 |
| 11 | M65810573750 | 1057375 | NA | Software, Delivery Analysis, Version 1.2 | Delivery Analysis TM | ACCURAY INCORPORATED |
| 12 | 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. | Accuray Precision® Treatment Planning System | ACCURAY INCORPORATED |
| 13 | M65810525910 | 1052591 | NA | Software, Delivery Analysis, Version 1.1 | Delivery Analysis TM | ACCURAY INCORPORATED |
| 14 | 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. | Accuray Precision® Treatment Planning System | ACCURAY INCORPORATED |
| 15 | 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. | Onrad Treatment System | ACCURAY INCORPORATED |
| 16 | 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 |
| 17 | M65810182860 | 1018286-000 | NA | TomoTherapy Treatment System (H Series) | TomoHDA® Treatment Delivery System | ACCURAY INCORPORATED |
| 18 | M65810182840 | 1018284-000 | NA | TomoTherapy® Treatment System (H Series) | TomoH® Treatment Delivery System | ACCURAY INCORPORATED |
| 19 | M65810182830 | 1018283-000 | NA | TomoTherapy Treatment System (H Series) | TomoHD® Treatment Delivery System | ACCURAY INCORPORATED |
| 20 | 08717213053717 | 170538-00 | Oncentra External Beam 4.5.3/Oncentra Brachy v4.6 | NA | NUCLETRON B.V. | |
| 21 | 08717213053700 | 170018-00 | Oncentra External Beam 4.5.3/Oncentra Brachy v4.6 | NA | NUCLETRON B.V. | |
| 22 | 08717213052758 | 170607-00 | Oncentra External Beam Oncentra Brachy v4.6.1 | NA | NUCLETRON B.V. | |
| 23 | 08717213052321 | 170537-08 | Oncentra External Beam/Oncentra Brachy v4.5.3 | NA | NUCLETRON B.V. | |
| 24 | 08717213052314 | 170003-28 | Oncentra External Beam/Oncentra Brachy v4.5.3 | NA | NUCLETRON B.V. | |
| 25 | 08717213052307 | 170537-06 | Oncentra External Beam/Oncentra Brachy v4.5.3 | NA | NUCLETRON B.V. | |
| 26 | 08717213052291 | 170003-27 | Oncentra External Beam/Oncentra Brachy v4.5.3 | NA | NUCLETRON B.V. | |
| 27 | 08717213052246 | 170537-06 | Oncentra External Beam/Oncentra Brachy v4.5.3 | NA | NUCLETRON B.V. | |
| 28 | 08717213052239 | 170003-25 | Oncentra External Beam/Oncentra Brachy v4.5.3 | NA | NUCLETRON B.V. | |
| 29 | 08717213051881 | 170537-05 | Oncentra External Beam/Oncentra Brachy v4.5.2 | NA | NUCLETRON B.V. | |
| 30 | 08717213051782 | 170537-04 | Oncentra External Beam/Oncentra Brachy v4.5.2 | NA | NUCLETRON B.V. | |
| 31 | 08717213051775 | 170003-23 | Oncentra External Beam/Oncentra Brachy v4.5.2 | NA | NUCLETRON B.V. | |
| 32 | 08717213051294 | 170730 | Oncentra External Beam/Oncentra Brachy v4.5.2 | NA | NUCLETRON B.V. | |
| 33 | 08717213038677 | Oncentra External Beam | Oncentra External Beam v4.5 | NA | NUCLETRON B.V. | |
| 34 | 08717213038660 | Oncentra Brachy | Oncentra Brachy v4.5 | NA | NUCLETRON B.V. | |
| 35 | 08717213020610 | 170730 | Oncentra External Beam/Oncentra Brachy v4.5.2 | NA | NUCLETRON B.V. | |
| 36 | 08436567540017 | 4 | Radiance V4 is a software system intended for treatment planning and analysis of Radiance V4 is a software system intended for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy.The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.The system functionality can be configured based on user needs.The intended users of Radiance V4 shall be clinically qualified radiation therapy staff trained in using the system. | radiance | GMV SOLUCIONES GLOBALES INTERNET SA | |
| 37 | 08436567540000 | 3 | Radiance V3 is a software system intended for treatment planning and analysis of Radiance V3 is a software system intended for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy.The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.The system functionality can be configured based on user needs.The intended users of Radiance V3 shall be clinically qualified radiation therapy staff trained in using the system. | radiance | GMV SOLUCIONES GLOBALES INTERNET SA | |
| 38 | 07350002010532 | 5B SP1 | RayCare | RAYSEARCH LABORATORIES AB (PUBL) | ||
| 39 | 07350002010501 | 11B SP2 | RayStation | RAYSEARCH LABORATORIES AB (PUBL) | ||
| 40 | 07350002010495 | 11B SP1 | RayStation | RAYSEARCH LABORATORIES AB (PUBL) | ||
| 41 | 07350002010471 | 10B SP1 | RayStation | RAYSEARCH LABORATORIES AB (PUBL) | ||
| 42 | 07350002010464 | 5A SP1 | RayCare | RAYSEARCH LABORATORIES AB (PUBL) | ||
| 43 | 07350002010440 | 11A SP2 | RayStation | RAYSEARCH LABORATORIES AB (PUBL) | ||
| 44 | 07350002010433 | 11.0.1 | RayStation | RAYSEARCH LABORATORIES AB (PUBL) | ||
| 45 | 07350002010426 | 11B | RayStation | RAYSEARCH LABORATORIES AB (PUBL) | ||
| 46 | 07350002010419 | 4.1.1 | RayCare | RAYSEARCH LABORATORIES AB (PUBL) | ||
| 47 | 07350002010396 | 5.0 | RayCare | RAYSEARCH LABORATORIES AB (PUBL) | ||
| 48 | 07350002010389 | 11.0 | RayStation | RAYSEARCH LABORATORIES AB (PUBL) | ||
| 49 | 07350002010365 | 10.0.1 | RayStation | RAYSEARCH LABORATORIES AB (PUBL) | ||
| 50 | 07350002010358 | 4.1 | RayCare | RAYSEARCH LABORATORIES AB (PUBL) |