| 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 | 08717213052314 | 170003-28 | Oncentra External Beam/Oncentra Brachy v4.5.3 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 29 | 08717213052307 | 170537-06 | Oncentra External Beam/Oncentra Brachy v4.5.3 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 30 | 08717213052291 | 170003-27 | Oncentra External Beam/Oncentra Brachy v4.5.3 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 31 | 08717213052246 | 170537-06 | Oncentra External Beam/Oncentra Brachy v4.5.3 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 32 | 08717213052239 | 170003-25 | Oncentra External Beam/Oncentra Brachy v4.5.3 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 33 | 08717213051881 | 170537-05 | Oncentra External Beam/Oncentra Brachy v4.5.2 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 34 | 08717213051843 | 170003-24 | Oncentra External Beam/Oncentra Brachy v4.5.2 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 35 | 08717213051799 | 089013P02-00 | Obturator for 1.5mm Needle x 200mm | JAQ | System, applicator, radionuclide, remote-controlled | NA | ||
| 36 | 08717213051782 | 170537-04 | Oncentra External Beam/Oncentra Brachy v4.5.2 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 37 | 08717213051775 | 170003-23 | Oncentra External Beam/Oncentra Brachy v4.5.2 | MUJ | System,planning,radiation therapy treatment | 2 | NA | |
| 38 | 08717213034532 | 189735-06 | Ovoid Tube 1 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 39 | 08717213051584 | 083926P02-00 | Trocar Needle 1.5mm x 200mm | JAQ | System, applicator, radionuclide, remote-controlled | NA | ||
| 40 | 08717213051379 | 189731P01-01 | Screw Pin | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 41 | 08717213051362 | 189727P01-01 | Fixation Clip Screw | JAQ | System, applicator, radionuclide, remote-controlled | 2 | NA | |
| 42 | 08717213051294 | 170730 | Oncentra External Beam/Oncentra Brachy v4.5.2 | MUJ | System,planning,radiation therapy treatment | 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 | 01868603000212 | version 5.0 | Panther Brachy | PROWESS, INC. | ||
| 2 | 00884838112742 | RTgo 5 | 781439 | MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes t MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation therapy planning purposes. MR-RT consists of RTGo SW and MR CouchTop accessory. RTgo is a software that provides MR-RT functionality including MRCAT (MRCAT Prostate, MRCAT Pelvis, MRCAT Brain, MRCAT Head &Neck) | MR-RT | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| 3 | 00884838107311 | RTgo 5.0 5 | 300005806302 | MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes t MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation therapy planning purposes. MR-RT consists of RTGo SW and MR CouchTop accessory. RTgo is a softwar | MR-RT | PHILIPS OY |
| 4 | 00884838103566 | 18.0 | 45980171803X | Pinnacle Radiation Therapy Planning System | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. | |
| 5 | 00884838102965 | 16.4 | 45980163082X | Pinnacle Radiation Therapy Planning System | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. | |
| 6 | 00884838098992 | 459801630821 | 459801630821 | Pinnacle Radiation Therapy Planning System Version 16.4.0.60093 | Philips | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. |
| 7 | 00884838098206 | MRCAT Brain / RTgo 4.1 | 781439 | MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes t MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation therapy planning purposes. MR-RT consists of RTGo SW and MR CouchTop accessory. RTgo is a software that provides MR-RT functionality including MRCAT (MRCAT Prostate, MRCAT Pelvis, MRCAT Brain) | MR-RT | PHILIPS OY |
| 8 | 00884838094093 | MRCAT Brain / RTgo 4.0 | 781439 | MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes t MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation therapy planning purposes. MR-RT consists of RTGo SW and MR CouchTop accessory. RTgo is a software that provides MR-RT functionality including MRCAT (MRCAT Prostate, MRCAT Pelvis, MRCAT Brain) | MR-RT | PHILIPS OY |
| 9 | 00884838092112 | 459801266633 | MR-RT RTgo software USB stick | RTgo | PHILIPS OY | |
| 10 | 00884838091122 | 459801419352 | 459801419352 | Pinnacle3 Radiation therapy treatment planning system version 16.2.1.60098 | Philips | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. |
| 11 | 00884838085602 | 459801050602 | 459801050602 | Pinnacle Radiation Therapy Planning System Version 16.0.1.60003 | Philips | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. |
| 12 | 00884838084667 | 989603083082 | MR-RT RTgo software USB stick | RTgo | PHILIPS OY | |
| 13 | 00884838074200 | 459801050601 | 459801050601 | Pinnacle Radiation Therapy Planning System Version 16.0.0.60013 | Philips | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. |
| 14 | 00868603000236 | version 5.51 | The purpose of Prowess Panther TPS is to provide a complete program for radiatio The purpose of Prowess Panther TPS is to provide a complete program for radiation therapy treatment planning. This includes computation, display, evaluation, and output documentation of radiation dose estimations to be submitted for independent clinical review and judgment prior to use. The device provides data in the form of display, hardcopy prints and/or plots to guide a physician in selecting the optimum patient treatment plan. Panther treatment planning system allows radiation physicians, physicists, and dosimetrists to optimize the delivery of radiation in treating cancer and related diseases. | Panther TPS | PROWESS, INC. | |
| 15 | 00867520000206 | RadCalc® | RadCalc®#1 Trusted Dosimetric Verification Software.RadCalc Software.LifeLine So RadCalc®#1 Trusted Dosimetric Verification Software.RadCalc Software.LifeLine Software, Inc. | RadCalc® | LIFELINE SOFTWARE INC | |
| 16 | 00861572000313 | Dream Sensor Size 2 | DentiMax intraoral digital x-ray system, Size 2 Sensor. | DentiMax | DENTIMAX LLC | |
| 17 | 00861572000306 | Dream Sensor Size 1 | DentiMax intraoral digital x-ray system, Size 1 Sensor. | DentiMax | DENTIMAX LLC | |
| 18 | 00860007402333 | N/A | ADPT-ONDEM-3DPRT | Adaptiiv’s 3D printed patient-matched radiation therapy accessory is a customiza Adaptiiv’s 3D printed patient-matched radiation therapy accessory is a customizable accessory that expands the application of external beam radiation therapy, allowing to overcome the skin-sparing effects inherent to high energy photons and electrons. The desired external beam radiation therapy accessories will be printed using HP Jet Fusion 5200 Series 3D Printing Solution and Ultrasint® Thermoplastic polyurethane (TPU01) powder. | Patient-Matched 3D Printed radiation Therapy Accessory (Ultrasint TPU) | ADAPTIIV MEDICAL TECHNOLOGIES INC |
| 19 | 00860007402326 | v2021.1.0 | 3D Brachy Software application is indicated for and intended for use as an acces 3D Brachy Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during surface brachytherapy. The use of 3D Brachy application is by prescription only. | 3D Brachy Application | ADAPTIIV MEDICAL TECHNOLOGIES INC | |
| 20 | 00860007402319 | v2021.1.0 | 3D Bolus Software application is indicated for and intended for use as an access 3D Bolus Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during external beam (photon or electron) radiation therapy. The use of 3D Bolus application is by prescription only. | 3D Bolus Application | ADAPTIIV MEDICAL TECHNOLOGIES INC | |
| 21 | 00860007402302 | v3.0.0 | 3D Bolus Software is indicated for, and intended for use as an accessory to a ra 3D Bolus Software is indicated for, and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-specific 3D-printable objects intended for use during external beam photon or electron radiation therapy, or brachytherapy. | 3D Bolus Software | ADAPTIIV MEDICAL TECHNOLOGIES INC | |
| 22 | 00860004284901 | System | Oncospace | ONCOSPACE, INC. | ||
| 23 | 00860003983805 | RXM1000 | The RefleXion Medical Radiotherapy System (RMRS), a hybrid imaging-therapy syste The RefleXion Medical Radiotherapy System (RMRS), a hybrid imaging-therapy system, is capable ofdelivering intensity-modulated radiation therapy (IMRT), stereotactic body radiation therapy (SBRT),stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS) utilizing an on-board kilovoltage CT(kVCT) system for patient localization and field sizes based on jaws which are 40 cm wide, with slice widthchoices of 1.0 cm and 2.0 cm to optimize patient treatment. It is also equipped with a binary multileafcollimator (MLC) used to create intensity modulated radiation fields at a source-axis distance of 85 cm. Itcan achieve a nominal dose rate of 850 cGy/min. | Reflexion Medical Radiotherapy System | REFLEXION MEDICAL, INC. | |
| 24 | 00860001672725 | 2.0 | ClearCalc is a software intended to assist radiation treatment planners in deter ClearCalc is a software intended to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm. | ClearCalc | RADFORMATION, INC | |
| 25 | 00860001672718 | 2.3 | EZFluence is intended to assist radiation treatment planning professionals in ge EZFluence is intended to assist radiation treatment planning professionals in generating optimal fluences for producing a homogeneous dose distribution in external beam radiation therapy treatment plans consisting of photo treatment fields. | EZFluence | RADFORMATION, INC | |
| 26 | 00859032007132 | 5.7 | Panther TPS | PROWESS, INC. | ||
| 27 | 00859032007095 | v2.31 | Panther OIS R&V | PROWESS, INC. | ||
| 28 | 00859032007088 | v5.61 | Panther TPS | PROWESS, INC. | ||
| 29 | 00859032007064 | v5.6 | Panther TPS | PROWESS, INC. | ||
| 30 | 00859032007002 | version 5.0 | Panther Brachy | PROWESS, INC. | ||
| 31 | 00858164002275 | Monaco | Monaco | ELEKTA SOLUTIONS AB | ||
| 32 | 00858164002268 | Monaco | Monaco | ELEKTA, INC. | ||
| 33 | 00858164002244 | Monaco | Monaco | ELEKTA, INC. | ||
| 34 | 00858164002213 | ERGO Localizer | ERGO Localizer | ELEKTA, INC. | ||
| 35 | 00858164002206 | ERGO++ | ERGO++ | ELEKTA, INC. | ||
| 36 | 00858164002190 | Monaco | Monaco | ELEKTA, INC. | ||
| 37 | 00858164002183 | Monaco | Monaco | ELEKTA, INC. | ||
| 38 | 00858164002169 | Monaco | Monaco | ELEKTA, INC. | ||
| 39 | 00858164002152 | Monaco | Monaco | ELEKTA, INC. | ||
| 40 | 00858164002114 | XiO | XiO | ELEKTA, INC. | ||
| 41 | 00858164002046 | Monaco | Monaco | ELEKTA, INC. | ||
| 42 | 00858164002039 | Atlas-Based Autosegmentation | Atlas-Based Autosegmentation | ELEKTA, INC. | ||
| 43 | 00856100006264 | 1.1 | Ethos™ Treatment Planning | VARIAN MEDICAL SYSTEMS, INC. | ||
| 44 | 00856100006233 | 1.1 | Varian AI Segmentation | VARIAN MEDICAL SYSTEMS, INC. | ||
| 45 | 00856100006172 | 1.0 | Varian AI Segmentation | VARIAN MEDICAL SYSTEMS, INC. | ||
| 46 | 00856100006141 | 1.0 | Varian Ethos Treatment Planning | VARIAN MEDICAL SYSTEMS, INC. | ||
| 47 | 00856100006059 | 15.1 | Smart Segmentation Knowledge Based Contouring | VARIAN MEDICAL SYSTEMS, INC. | ||
| 48 | 00856100006011 | 15.0 | Smart Segmentation - Knowledge Based Contouring | VARIAN MEDICAL SYSTEMS IMAGING LABORATORY GMBH | ||
| 49 | 00855141006080 | 16.1 | Eclipse Treatment Planning System for External Beam Radiation Therapy | VARIAN MEDICAL SYSTEMS, INC. | ||
| 50 | 00855141006073 | 16.0 | Eclipse Treatment Planning System for External Beam Radiation Therapy | VARIAN MEDICAL SYSTEMS, INC. |