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 | 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 |
6 | 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 |
7 | 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 |
8 | 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 |
9 | 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+. | LHO | Instrument, Quality-Assurance, Radiologic | 1 | HexaMotion |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B365805000 | 80-500 | Navigator CS | AKTINA CORP. | ||
2 | B365702100 | 70-210 | Prone Breast Immobilization System | AKTINA CORP. | ||
3 | B365702000 | 70-200 | SenoView Prone Breast System | AKTINA CORP. | ||
4 | B365701000 | 70-100 | SenoView Prone Breast Board | AKTINA CORP. | ||
5 | B365608120 | 60-812 | ArmCradle4 | AKTINA CORP. | ||
6 | B365605800 | 60-580 | ArmCradle3 | AKTINA CORP. | ||
7 | B365605600 | 60-560 | Arm Cradle | AKTINA CORP. | ||
8 | B365605500 | 60-550 | Foot Stabilizer | AKTINA CORP. | ||
9 | B365605450 | 60-545 | Indexing Bar | AKTINA CORP. | ||
10 | B365605430 | 60-543 | Adjustable Knee Support | AKTINA CORP. | ||
11 | B365605400 | 60-540 | Knee Support | AKTINA CORP. | ||
12 | B365605250 | 60-525 | Paddle | AKTINA CORP. | ||
13 | B365605220 | 60-522 | SBRT Universal Crossbar | AKTINA CORP. | ||
14 | B365605200 | 60-520 | Crossbar Assembly | AKTINA CORP. | ||
15 | B365605100 | 60-510 | Head Support System | AKTINA CORP. | ||
16 | B365605000 | 60-500 | Memorial Body Cradle | AKTINA CORP. | ||
17 | B365603120 | 60-312 | Respiratory Belt with Bladder, Large | AKTINA CORP. | ||
18 | B365603110 | 60-311 | Respiratory Belt with Bladder, Medium | AKTINA CORP. | ||
19 | B365603100 | 60-310 | Respiratory Belt with Bladder, Small | AKTINA CORP. | ||
20 | B365602800 | 60-280 | Localization Bridge | AKTINA CORP. | ||
21 | B365602300 | 60-230 | Wrist and Forearm Support | AKTINA CORP. | ||
22 | B365602200 | 60-220 | Hip-Knee-Foot Immobilizer | AKTINA CORP. | ||
23 | B365601900 | 60-190 | Belly Compression Arch Kit | AKTINA CORP. | ||
24 | B365601700 | 60-170 | PinPoint C-Spine Kit | AKTINA CORP. | ||
25 | B365601600 | 60-160 | Overhead Arm Support | AKTINA CORP. | ||
26 | B365601500 | 60-150 | Shoulder Restraint | AKTINA CORP. | ||
27 | B365601400 | 60-140 | Hand Grip | AKTINA CORP. | ||
28 | B365601200 | 60-120 | Crossbar Assembly | AKTINA CORP. | ||
29 | B365601100 | 60-110 | Frame Assembly | AKTINA CORP. | ||
30 | B365601000 | 60-100 | Memorial Body Cradle, Base System | AKTINA CORP. | ||
31 | B365579050 | 57-905 | Smart Tray, Siemens, Star Hole Pattern, Lexan, Cross-Hairs | AKTINA CORP. | ||
32 | B365579010 | 57-901 | Smart Tray, Siemens, Solid, Lexan, Cross-Hairs | AKTINA CORP. | ||
33 | B36556300MX600 | 56-300-MX60 | Wedge Filter, Cross- Plane, MLC, 60 Degrees, Siemens | AKTINA CORP. | ||
34 | B36556300MX450 | 56-300-MX45 | Wedge Filter, Cross- Plane, MLC, 45 Degrees, Siemens | AKTINA CORP. | ||
35 | B36556300MX300 | 56-300-MX30 | Wedge Filter, Cross- Plane, MLC, 30 Degrees, Siemens | AKTINA CORP. | ||
36 | B36556300MX150 | 56-300-MX15 | Wedge Filter, Cross- Plane, MLC, 15 Degrees, Siemens | AKTINA CORP. | ||
37 | B36556300MI600 | 56-300-MI60 | Wedge Filter, In- Plane, MLC, 60 Degrees, Siemens. | AKTINA CORP. | ||
38 | B36556300MI450 | 56-300-MI45 | Wedge Filter, In- Plane, MLC, 45 Degrees, Siemens | AKTINA CORP. | ||
39 | B36556300MI300 | 56-300-MI30 | Wedge Filter, In- Plane, MLC, 30 Degrees, Siemens | AKTINA CORP. | ||
40 | B36556300MI150 | 56-300-MI15 | Wedge Filter, In- Plane, MLC, 15 Degrees, Siemens. | AKTINA CORP. | ||
41 | B36556300DX600 | 56-300-DX60 | Wedge Filter, Cross- Plane, Digital, 60 Degrees, Siemens | AKTINA CORP. | ||
42 | B36556300DX450 | 56-300-DX45 | Wedge Filter, Cross- Plane, Digital, 45 Degrees, Siemens | AKTINA CORP. | ||
43 | B36556300DX300 | 56-300-DX30 | Wedge Filter, Cross- Plane, Digital, 30 Degrees, Siemens | AKTINA CORP. | ||
44 | B36556300DX150 | 56-300-DX15 | Wedge Filter, Cross- Plane, Digital, 15 Degrees, Siemens | AKTINA CORP. | ||
45 | B36556300DI600 | 56-300-DI60 | Wedge Filter, In- Plane, Digital, 60 Degrees, Siemens | AKTINA CORP. | ||
46 | B36556300DI450 | 56-300-DI45 | Wedge Filter, In- Plane, Digital, 45 Degrees, Siemens | AKTINA CORP. | ||
47 | B36556300DI300 | 56-300-DI30 | Wedge Filter, In- Plane, Digital, 30 Degrees, Siemens | AKTINA CORP. | ||
48 | B36556300DI150 | 56-300-DI15 | Wedge Filter, In- Plane, Digital, 15 Degrees, Siemens | AKTINA CORP. | ||
49 | B365562910 | 56-291 | Carbon Fiber Center-Spine Insert, Siemens | AKTINA CORP. | ||
50 | B365561100 | 56-110 | Patient Restraining Belt | AKTINA CORP. |