No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 17350005180093 | Wired (PW) | SDOS101-46 | The intended use of the device is• quality assurance of patient specific treatme The intended use of the device is• quality assurance of patient specific treatment delivery prior to the treatment in IMRT (including VMAT) and 4DRT (e.g. respiratory gating and tumour tracking).• quality assurance of the radiation delivery system. | IYE | Accelerator, Linear, Medical | 2 | Delta4 Phantom+ |
2 | 17350005180031 | IMRT (PMMA) | SDOS101-30 | The intended use of the device is• quality assurance of patient specific treatme The intended use of the device is• quality assurance of patient specific treatment delivery prior to the treatment in IMRT (including VMAT) and 4DRT (e.g. respiratory gating and tumour tracking).• quality assurance of the radiation delivery system. | IYE | Accelerator, Linear, Medical | 2 | Delta4 Phantom+ |
3 | 17350005180024 | Wired (PMMA) | SDOS101-35 | The intended use of the device is• quality assurance of patient specific treatme The intended use of the device is• quality assurance of patient specific treatment delivery prior to the treatment in IMRT (including VMAT) and 4DRT (e.g. respiratory gating and tumour tracking).• quality assurance of the radiation delivery system. | IYE | Accelerator, Linear, Medical | 2 | Delta4 Phantom+ |
4 | 17350005180017 | PW | SDOS101-21 | The intended use of the device is• quality assurance of patient specific treatme The intended use of the device is• quality assurance of patient specific treatment delivery prior to the treatment in IMRT (including VMAT) and 4DRT (e.g. respiratory gating and tumour tracking).• quality assurance of the radiation delivery system. | IYE | Accelerator, Linear, Medical | 2 | Delta4 Phantom+ |
5 | 17350005180000 | PMMA | SDOS101-20 | The intended use of the device is• quality assurance of patient specific treatme The intended use of the device is• quality assurance of patient specific treatment delivery prior to the treatment in IMRT (including VMAT) and 4DRT (e.g. respiratory gating and tumour tracking).• quality assurance of the radiation delivery system. | IYE | Accelerator, Linear, Medical | 2 | Delta4 Phantom+ |
6 | 17350005180079 | Elekta | SDOS105-02 | The intended use of the device is• quality assurance of patient specific treatme The intended use of the device is• quality assurance of patient specific treatment delivery during and before external radiotherapy treatment, including IMRT, VMAT and 4DRT (respiratory gating and tumour tracking)• quality assurance of the radiation delivery system. | IYE | Accelerator, Linear, Medical | 2 | Delta4 Discover |
7 | 17350005180062 | SDOS105-01 | SDOS105-01 (Varian) | The intended use of the device is• quality assurance of patient specific treatme The intended use of the device is• quality assurance of patient specific treatment delivery during and before external radiotherapy treatment, including IMRT, VMAT and 4DRT (respiratory gating and tumour tracking)• quality assurance of the radiation delivery system. | IYE | Accelerator, Linear, Medical | 2 | Delta4 Discover |
8 | 17350005180086 | PW | SDOS101-34 | The intended use of the device is• quality assurance of patient specific treatme The intended use of the device is• quality assurance of patient specific treatment delivery prior to the treatment in IMRT (including VMAT) and 4DRT (e.g. respiratory gating and tumour tracking).• quality assurance of the radiation delivery system. | IYE | Accelerator, Linear, Medical | 2 | Delta4 Phantom+ MR |
9 | 17350005180048 | PMMA | SDOS101-36 | The intended use of the device is• quality assurance of patient specific treatme The intended use of the device is• quality assurance of patient specific treatment delivery prior to the treatment in IMRT (including VMAT) and 4DRT (e.g. respiratory gating and tumour tracking).• quality assurance of the radiation delivery system. | IYE | Accelerator, Linear, Medical | 2 | Delta4 Phantom+ MR |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B136RC10000 | RC1000 | The RapidCHECK platform is intended for supporting users in analyzing diagnostic The RapidCHECK platform is intended for supporting users in analyzing diagnostic imaging data to ensure the performance of the diagnostic system is operating within safe and expected tolerances. | RapidCheck | GAMMEX, INC. | |
2 | B136AP60 | AP6 | Sun Nuclear | GAMMEX, INC. | ||
3 | B1365570 | 557 | Sun Nuclear | GAMMEX, INC. | ||
4 | B1364870 | 487 | Sun Nuclear B200 Bone Mineral | GAMMEX, INC. | ||
5 | B1364850 | 485 | Sun Nuclear LN-450 Lung TMM | GAMMEX, INC. | ||
6 | B1364840 | 484 | Sun Nuclear CB2 + 30% CaCO3 TMM | GAMMEX, INC. | ||
7 | B1364830 | 483 | Sun Nuclear CB2 + 10% CaCO3 TMM | GAMMEX, INC. | ||
8 | B1364820 | 482 | Sun Nuclear LV1 Liver TMM | GAMMEX, INC. | ||
9 | B1364810 | 481 | Sun Nuclear BRN-SR2 Brain | GAMMEX, INC. | ||
10 | B1364800 | 480 | Sun Nuclear CB2 + 50% CaCO3 | GAMMEX, INC. | ||
11 | B136468BHP0 | 468BHP | Sun Nuclear CT Dose Index Phantom | GAMMEX, INC. | ||
12 | B136468BH0 | 468BH | Sun Nuclear CT Dose Index | GAMMEX, INC. | ||
13 | B1364670 | 467 | Sun Nuclear CT Electron Density Phantom | GAMMEX, INC. | ||
14 | B1364640 | 464 | Sun Nuclear CT ACR 464 Phantom | GAMMEX, INC. | ||
15 | B1364570 | 457 | Sun Nuclear Original Solid Water | GAMMEX, INC. | ||
16 | B1364560 | 456 | Sun Nuclear IB3 Inner Bone | GAMMEX, INC. | ||
17 | B1364550 | 455 | Sun Nuclear LN-300 Lung | GAMMEX, INC. | ||
18 | B1364540 | 454 | Sun Nuclear BR12 Breast | GAMMEX, INC. | ||
19 | B1364530 | 453 | Sun Nuclear BR12 Breast | GAMMEX, INC. | ||
20 | B1364520 | 452 | Sun Nuclear MS11 Muscle | GAMMEX, INC. | ||
21 | B1364510 | 451 | Sun Nuclear CT Solid Water | GAMMEX, INC. | ||
22 | B1364500 | 450 | Sun Nuclear SB3 Cortical Bone | GAMMEX, INC. | ||
23 | B136411LE0 | TMM | Sun Nuclear Tissue Mimicking Phantom | GAMMEX, INC. | ||
24 | B13628230 | 2823 | Sun Nuclear MultiPHAN Phantom Kit | GAMMEX, INC. | ||
25 | B1362000 | 200 | Sun Nuclear Low Contrast Test Tool | GAMMEX, INC. | ||
26 | B136161B0 | 161B | Sun Nuclear Collimator Test Tool Stainless Steel | GAMMEX, INC. | ||
27 | B136159ABR0 | 159ABR | Sun Nuclear Phototimer Consistency Tools | GAMMEX, INC. | ||
28 | B136159A0 | 159A | Phototimer Consistency Tools | GAMMEX, INC. | ||
29 | B136156D0 | 156D | Sun Nuclear Mammo 156D Stereo Phantom | GAMMEX, INC. | ||
30 | B1361560 | 156 | Sun Nuclear Mammo 156 Phantom | GAMMEX, INC. | ||
31 | B13614720 | 1472 | Sun Nuclear Multi-Energy CT Phantom | GAMMEX, INC. | ||
32 | B13614670 | 1467 | Sun Nuclear Advanced Electron Density Phantom | GAMMEX, INC. | ||
33 | B13614640 | 1464 | Sun Nuclear Advanced iqModule | GAMMEX, INC. | ||
34 | B136115H0 | 115H | Sun Nuclear 115H Half Value Layer Attenuator Set | GAMMEX, INC. | ||
35 | B1361150 | 115A | Sun Nuclear 115A Half Value Layer Attenuator Set | GAMMEX, INC. | ||
36 | B01612200003Z0 | 12200003Z | 12200003Z | Accessory to Models 1220 ArcCHECK and 1220-MR ArcCHECK-MR. | ArcCHECK PMMA MultiPlug | SUN NUCLEAR CORP. |
37 | B01612200001Z0 | 12200001Z | 12200001Z | Accessory to Models 1220 ArcCHECK and 1220-MR ArcCHECK-MR. | ArcCHECK Cavity Plug | SUN NUCLEAR CORP. |
38 | B01610460001Z0 | 10460001Z | 10460001Z | Radiation therapy QA device. | REFERENCE DETECTOR (TNC) | SUN NUCLEAR CORP. |
39 | B01610460000Z0 | 10460000Z | 10460000Z | Radiation therapy QA device. | REFERENCE DETECTOR (BNC) | SUN NUCLEAR CORP. |
40 | 17350005180055 | SDOS104-05 | SDOS104-05 | The intended use of the device is to realize a multi-dimensional movement patter The intended use of the device is to realize a multi-dimensional movement pattern, e.g. of the Delta4PT or the Delta4 Phantom+. | HexaMotion | SCANDIDOS AB |
41 | 09421904268302 | 4.0 | VolparaDoseSR 4.0 | VolparaDoseSR | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
42 | 09421904268296 | 4.0 | VolparaDoseRT 4.0 | VolparaDoseRT | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
43 | 09421904268272 | 3.4.2 | VolparaDoseSR 3.4.2 | VolparaDoseSR | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
44 | 09421904268265 | 3.4.2 | VolparaDoseRT 3.4.2 | VolparaDoseRT | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
45 | 09421904268104 | 3.3 | VolparaDoseRT 3.3 (including VolparaPressure and VolparaPosition) | VolparaDoseRT | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
46 | 09421904268043 | 3.2 | VolparaDoseSR 3.2 | VolparaDoseSR | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
47 | 09421904268036 | 3.2 | VolparaDoseRT 3.2 | VolparaDoseRT | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
48 | 05415334002449 | V2.xx | K5402901 | QAWeb Enterprise Web Client | QAWeb Enterprise | BARCO NV |
49 | 05415334002432 | V2.xx | K5402921 | QAWeb Enterprise Agent | QAWeb Enterprise | BARCO NV |
50 | 05060608880959 | 1096300Z | 1093000-0MRZ | Radiation therapy QA device. | Daily QA-MR | SUN NUCLEAR CORP. |