Accelerator, Linear, Medical
CT Localisation set for Titanium & Aluminium Headring
8manufacturers in China registered for this device type
42catalogue numbers in this listing
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 | Inomed Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | IYE |
| Device type | Accelerator, Linear, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Establishment | Manufacturer |
| Record published | 2022-09-27 |
| Record revised | 2025-06-02 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 801006 | In distribution | ||
| 802010 | In distribution | ||
| 899040 | In distribution | ||
| 801009 | In distribution | ||
| 803013 | 4 | In distribution | |
| 803111 | In distribution | ||
| 803930 | In distribution | ||
| 803222 | In distribution | ||
| 801012 | In distribution | ||
| 801004 | In distribution | ||
| 803012 | 4 | In distribution | |
| 803226 | In distribution | ||
| 803405 | In distribution | ||
| 801003 | In distribution | ||
| 803104 | In distribution | ||
| 803410 | In distribution | ||
| 801005 | In distribution | ||
| 803906 | In distribution | ||
| 801014 | In distribution | ||
| 809200 | In distribution | ||
| 803223 | In distribution | ||
| 801016 | In distribution | ||
| 803224 | In distribution | ||
| 803420 | In distribution | ||
| 801018 | In distribution | ||
| 803225 | In distribution | ||
| 803340 | In distribution | ||
| 801031 | In distribution | ||
| 809050 | In distribution | ||
| 802020 | In distribution | ||
| 809101 | In distribution | ||
| 803960 | In distribution | ||
| 803950 | In distribution | ||
| 803940 | In distribution | ||
| 801000 | In distribution | ||
| 803110 | In distribution | ||
| 803404 | In distribution | ||
| 801015 | In distribution | ||
| 803401 | In distribution | ||
| 801013 | In distribution | ||
| 801007 | In distribution | ||
| 801008 | 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
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.