Bionix Radiation Therapy
Pelvis Belly: GEN3 PAD SET Assembly W/ Medium AND Small Inserts
8manufacturers in China registered for this device type
115catalogue 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 | Bionix Radiation Therapy, LLC |
|---|---|
| FDA product code | IYE |
| Device type | Accelerator, Linear, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| 510(k) | K100691 |
| Record published | 2017-04-25 |
| Record revised | 2023-07-10 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 6, box of 10, box of 5, box of 4 |
| Distribution end date | 2020-10-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SVRT-9820 | Withdrawn | |
| UTRT-5012A | Withdrawn | |
| UTRT-5018 | Withdrawn | |
| HNRT-7040 | Withdrawn | |
| SBRT-4500 | Withdrawn | |
| SVRT-7108 | Withdrawn | |
| UTRT-7527 | Withdrawn | |
| UTRT-5007 | Withdrawn | |
| HNRT-5049 | Withdrawn | |
| SBRT-4650 | Withdrawn | |
| UTRT-5010A | Withdrawn | |
| SVRT-7140 | Withdrawn | |
| SVRT-7130 | Withdrawn | |
| UTRT-7010 | Withdrawn | |
| SVRT-9450 | Withdrawn | |
| EMRT-8331 | Withdrawn | |
| HNRT-7011 | Withdrawn | |
| SVRT-7133 | Withdrawn | |
| BKRT-5038 | Withdrawn | |
| SVRT-7380-A | Withdrawn | |
| HNRT-6039 | Withdrawn | |
| EMRT-8420 | Withdrawn | |
| EMRT-8365 | Withdrawn | |
| HNRT-6060 | Withdrawn | |
| SVRT-7915 | Withdrawn | |
| SVRT-7131 | Withdrawn | |
| UTRT-5009 | Withdrawn | |
| HNRT-7029 | Withdrawn | |
| SVRT-7017 | Withdrawn | |
| EMRT-8355 | Withdrawn | |
| EMRT-8335 | Withdrawn | |
| EMRT-8370 | Withdrawn | |
| SVRT-7136 | Withdrawn | |
| SVRT-7635 | Withdrawn | |
| UTRT-7526 | Withdrawn | |
| EMRT-8415 | Withdrawn | |
| 4500-100A | Withdrawn | |
| EMRT-8330 | Withdrawn | |
| UTRT-5015 | Withdrawn | |
| UTRT-5527A | Withdrawn | |
| EMRT-8310 | Withdrawn | |
| PPRT-5106 | Withdrawn | |
| SVRT-7650 | Withdrawn | |
| EMRT-8320 | Withdrawn | |
| HNRT-3500 | Withdrawn | |
| SVRT-7535-A | Withdrawn | |
| EMRT-8305 | Withdrawn | |
| 4500-00-02 | Withdrawn | |
| BKRT-5036 | Withdrawn | |
| EMRT-8325 | Withdrawn | |
| SVRT-7450-A | Withdrawn | |
| EMRT-8385 | Withdrawn | |
| HNRT-7664 | Withdrawn | |
| BKRT-5038 | Withdrawn | |
| 7528-00-02 | Withdrawn | |
| EMRT-8425 | Withdrawn | |
| EMRT-8360 | Withdrawn | |
| EMRT-8430 | Withdrawn | |
| SVRT-7135 | Withdrawn | |
| EMRT-8340 | Withdrawn | |
| PBRT-6240 | Withdrawn | |
| UTRT-7020 | Withdrawn | |
| PPRT-5108 | Withdrawn | |
| UTRT-5008 | Withdrawn | |
| 4500-10-02 | Withdrawn | |
| UTRT-7019 | Withdrawn | |
| PBRT-6025-03 | Withdrawn | |
| HNRT-5039 | Withdrawn | |
| EMRT-8455 | Withdrawn | |
| EMRT-8740 | Withdrawn | |
| UTRT-5014A | Withdrawn | |
| EMRT-8400 | Withdrawn | |
| UTRT-5528 | Withdrawn | |
| SVRT-7625 | Withdrawn | |
| SVRT-7132 | Withdrawn | |
| HNRT-7040-02 | Withdrawn | |
| 6030-50 | Withdrawn | |
| 4500-20-02 | Withdrawn | |
| 00-0601 | Withdrawn | |
| 5105-00-03 | Withdrawn | |
| BKRT-5036 | Withdrawn | |
| UTRT-5035-R | Withdrawn | |
| 6030-30 | Withdrawn | |
| UTRT-5016 | Withdrawn | |
| UTRT-5043-A | Withdrawn | |
| HNRT-5029 | Withdrawn | |
| EMRT-8315 | Withdrawn | |
| EMRT-8375 | Withdrawn | |
| UTRT-5526 | Withdrawn | |
| HNRT-7045 | Withdrawn | |
| HNRT-3501 | Withdrawn | |
| EMRT-8410 | Withdrawn | |
| 4500-40-02 | Withdrawn | |
| SVRT-7715 | Withdrawn | |
| BKRT-5037 | Withdrawn | |
| HNRT-6042 | Withdrawn | |
| SVRT-7106 | Withdrawn | |
| SVRT-7107 | Withdrawn | |
| SVRT-7600 | Withdrawn | |
| SVRT-7134 | Withdrawn | |
| SVRT-7630 | Withdrawn | |
| EMRT-8345 | Withdrawn | |
| SVRT-7820-A | Withdrawn | |
| EMRT-8405 | Withdrawn | |
| UTRT-5035-L | Withdrawn | |
| EMRT-8440 | Withdrawn | |
| SVRT-9535 | Withdrawn | |
| EMRT-8380 | Withdrawn | |
| SVRT-6017 | Withdrawn | |
| UTRT-5032 | Withdrawn | |
| EMRT-8350 | Withdrawn | |
| 6026-00-02 | Withdrawn | |
| SBRT-4601 | Withdrawn | |
| 4500-30-02 | Withdrawn | |
| EMRT-8450 | Withdrawn |
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 |
| 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 |
| Gold Anchor | Naslund Medical AB | 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.