| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 04049223106492 | LAH02-11#03 | LAH02-11 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | X-Ray Marker 11, L=325mm | |
| 2 | 04049223118709 | LLZ03-02 | LLZ03-02 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | Channel Coding for Needles and Catheters (Channel 2) | |
| 3 | 04049223118860 | LLZ03-19 | LLZ03-19 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | Channel Coding for Needles and Catheters (Channel 19) | |
| 4 | 04049223118853 | LLZ03-18 | LLZ03-18 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | Channel Coding for Needles and Catheters (Channel 18) | |
| 5 | 04049223118570 | LLZ10-03 | LLZ10-03 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | Fixation cap d=7.1 | |
| 6 | 04049223116514 | LAZ24-12 | LAZ24-12 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | Bougie for Oesophagus, single-use, D=12mm (36Fr) | |
| 7 | 04049223116491 | LAZ24-08 | LAZ24-08 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | Bougie for Oesophagus, single-use, D=8mm (24Fr) | |
| 8 | 04049223114527 | LLH02-300 | LLH02-300 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | CT/MR Obturator for Plastic Needle, L= 300 mm (à 1 pc) | |
| 9 | 04049223114473 | LAZ08 | LAZ08 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | Nasopharynx Applicator (Rotterdam Type) | |
| 10 | 04049223108397 | LAR01-01 | LAR01-01 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | Intrauterine Tube, straight | |
| 11 | 04049223108304 | LLZ03-21 | LLZ03-21 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | Channel Coding for Needles and Catheters (Set for Channel 1-20) | |
| 12 | 04049223107987 | LLA1200-20#02 | LLA1200-20 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | Universal Applicator, marked, d=2mm, L=1200mm (sterile) | |
| 13 | 04049223107918 | LCT42-6#02 | LCT42-6 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | IU tube for Ring-Applicator CT/MR, 60°, IUL=20mm | |
| 14 | 04049223107901 | LCT42-3#02 | LCT42-3 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | 2-Channel-Ring-Applicator CT/MR, 60°, d=35mm | |
| 15 | 04049223107864 | LCT40-7 | LCT40-7 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | IU Tube for Ring-Applicator CT/MR, 30°, IUL=40mm | |
| 16 | 04049223107796 | LCR05-01#02 | LCR05-01 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | Intrauterine Tube, CT/MR, bent; IUL=35mm, 40° | |
| 17 | 04049223107444 | LA320-84 | LA320-84 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | Vaginal Cylinder, closed, D=30mm, L=130mm | |
| 18 | 04049223106652 | LAH02-27#03 | LAH02-27 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | X-Ray Marker 27, L=325mm | |
| 19 | 04049223106621 | LAH02-24#03 | LAH02-24 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | X-Ray Marker 24, L=325mm | |
| 20 | 04049223106546 | LAH02-16#03 | LAH02-16 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | X-Ray Marker 16, L=325mm | |
| 21 | 04049223106409 | LCT41-6 | LCT41-6 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | IU Tube for Ring-Applicator CT/MR, 45°, IUL=20mm | |
| 22 | 04049223106393 | LCT41-3#02 | LCT41-3 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | 2-Channel-Ring-Applicator CT/MR, 45°, d=35mm | |
| 23 | 04049223104832 | AGD.A26 | AGD.A26 | KXK | Source, Brachytherapy, Radionuclide | 2 | Dummy, silver, type CCB | |
| 24 | 04049223103149 | LAZ01-08#03 | LAZ01-08 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | Applicator-Fixation for Bougie D=8mm | |
| 25 | 04049223101244 | LCT05-01#03 | LCT05-01 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | CT/MR Intrauterine Tube 40°, thin, D=3.5mm, IUL=35mm | |
| 26 | 04049223100964 | RU6.A14-S | RU6.A14-S | KXK | Source, Brachytherapy, Radionuclide | 2 | Ru-106 Eye Applicator with slot, type CIB 18.9 MBq | |
| 27 | 04049223100896 | RU6.A09 | RU6.A09 | KXK | Source, Brachytherapy, Radionuclide | 2 | Ru-106 Eye Applicator, type COB 15 MBq | |
| 28 | 04049223100865 | RU6.A07 | RU6.A07 | KXK | Source, Brachytherapy, Radionuclide | 2 | Ru-106 Eye Applicator, type CGD 24 MBq | |
| 29 | 04049223100834 | RU6.A06 | RU6.A06 | KXK | Source, Brachytherapy, Radionuclide | 2 | Ru-106 Eye Applicator, type CCB 19 MBq | |
| 30 | 04049223100780 | RU6.A033 | RU6.A033 | KXK | Source, Brachytherapy, Radionuclide | 2 | Ru-106 Eye Applicator, type CXS 4 MBq | |
| 31 | 04049223100773 | RU6.A03 | RU6.A03 | KXK | Source, Brachytherapy, Radionuclide | 2 | Ru-106 Eye Applicator, type CCX 6 MBq | |
| 32 | 04049223108359 | LAR05-01 | LAR05-01 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | Intrauterine Tube, bent; IUL=35mm, 40° | |
| 33 | 04049223132613 | LAA1400-GYN#02 | LAA1400-GYN | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | Universal Applicator incl. plug, D=3mm, L=1400mm (non sterile) | |
| 34 | 04049223119010 | LCZ07-03-00 | LCZ07-03-00 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | CT/MR Cap, closed, D=30mm | |
| 35 | 04049223118877 | LLZ03-20 | LLZ03-20 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | Channel Coding for Needles and Catheters (Channel 20) | |
| 36 | 04049223118815 | LLZ03-14 | LLZ03-14 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | Channel Coding for Needles and Catheters (Channel 14) | |
| 37 | 04049223118808 | LLZ03-13 | LLZ03-13 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | Channel Coding for Needles and Catheters (Channel 13) | |
| 38 | 04049223118303 | LLA150-KB#02-5PC | LLA150-KB | JAQ | System, Applicator, Radionuclide, Remote-Controlled | Plastic Needle, D=1.65mm, L=150mm, 16G | ||
| 39 | 04049223118273 | LLA300-KB#02-5PC | LLA300-KB | JAQ | System, Applicator, Radionuclide, Remote-Controlled | Plastic Needle, D=1.65mm, L=300mm, 16G | ||
| 40 | 04049223118211 | 1374-0600#01 | 1374-0600 | MUJ | System,Planning,Radiation Therapy Treatment | 2 | SagiPlan® 2.x Software | |
| 41 | 04049223116446 | LAZ07-06 | LAZ07-06 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | Vaginal Cylinder with variable length, D=12.5mm, L=120mm | |
| 42 | 04049223116354 | LAA1400-GYN | LAA1400-GYN | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | Universal Applicator incl. plug, D=3mm, L=1400mm (non sterile) | |
| 43 | 04049223116095 | LLZ03-08 | LLZ03-08 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | Channel Coding for Needles and Catheters (Channel 8) | |
| 44 | 04049223114961 | 1321-0201 | 1321-0201 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | SagiNova®, HDR Afterloader, 25 channels, for Co-60 and Ir-192 | |
| 45 | 04049223114510 | LCZ52-01 | LCZ52-01 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | CT/MR Needle Collector | |
| 46 | 04049223114497 | LCZ50-01 | LCZ50-01 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | CT/MR Rectal Retractor | |
| 47 | 04049223108212 | LLZ02-01 | LLZ02-01 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | Fixation Cap for plastic needles | |
| 48 | 04049223108205 | LLS50 | LLS50 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | Connector for Universal Applicator, d=2mm | |
| 49 | 04049223107819 | LCR70-01#02 | LCR70-01 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | Endometrium-Applicator CT/MR, D=5mm | |
| 50 | 04049223107789 | LCR04-01#02 | LCR04-01 | JAQ | System, Applicator, Radionuclide, Remote-Controlled | 2 | Intrauterine Tube, CT/MR, bent; IUL=60mm |
| 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) |