Delta4 Discover
Delta4 Discover is a quality-assurance instrument for checking radiation treatment delivered by medical linear accelerators. It supports patient-specific delivery checks before and during…
Delta4 Discover is a quality-assurance instrument for checking radiation treatment delivered by medical linear accelerators. It supports patient-specific delivery checks before and during external radiotherapy, including intensity-modulated radiotherapy, volumetric-modulated arc therapy and respiratory-gated or tumor-tracking treatment.
A two-dimensional semiconductor detector matrix is inserted into the accelerator’s radiation field. Radiation striking the detectors creates signals that pass to a computer. Acquisition, display and analysis programs use those signals to map the delivered dose distribution.
Listed Item
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.
Dose Comparison
The measured distribution can be compared with the planned distribution. This information supports quantitative and visual assessment of treatment-planning and radiation-delivery system performance. The device also supports quality assurance of the radiation-delivery system itself.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (2), Beijing (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Tian Hong Medical Technology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 4 |
| Klarity Medical & Equipment (GZ) Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 3 |
| Elekta Beijing Medical Systems Co., Ltd. | Beijing | Beijing | Contract manufacturer | 1 |
| Manteia Technologies Co., Ltd. | Xiamen | Fujian | Manufacturer | 3 |
| OUR United Corporation | Xian | Shaanxi | Contract manufacturer | 2 |
| Suzhou Linatech Medical Science AND Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
| Varian Medical Systems China Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Jiangsu Rayer Medical Technology Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Scandidos AB, Sweden |
|---|---|
| FDA product code | IYE |
| Device type | Accelerator, Linear, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| 510(k) | K151426 |
| Record published | 2017-12-11 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Elekta | In distribution | |
| SDOS105-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Klarity Medical | Klarity Medical Products, LLC | 891 |
| Orfit Industries | Orfit Industries NV | 680 |
| Aquaplast RT™ | Qfix | 569 |
| Fibreplast® | Qfix | 271 |
| Bionix Radiation Therapy | Bionix Radiation Therapy, LLC | 115 |
| Vac-Lok™ Cushion | Medtec LLC | 100 |
| Visicoil | IZI Medical Products LLC | 86 |
| BodyFIX | 3C-Medical Intelligence GmbH | 84 |
| AlignRT Plus | Vision RT Limited | 72 |
| Fibreplast® Assure™ Open View | Qfix | 72 |
| Accelerator, Linear, Medical | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 71 |
| Thermoplastic Mask | IZI Medical Products LLC | 58 |
Showing 12 of 1,611. All products under Accelerator, Linear, Medical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223234 | 2024-01-16 |
| K183606 | 2019-04-08 |
| K151426 | 2016-01-29 |
| K151180 | 2015-08-19 |
| K052920 | 2006-01-12 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.