HP PRO Positioning Device
HP Pro Positioning Device extends the treatment-table support used for proton radiation therapy and radiosurgery. It attaches to the couch top with indexing and supports an immobilization…
HP Pro Positioning Device extends the treatment-table support used for proton radiation therapy and radiosurgery. It attaches to the couch top with indexing and supports an immobilization assembly placed on it. The patient is positioned on that assembly for treatment or repositioning.
The rectangular support is an accessory to the Proton Immobilization Solution. It can carry a baseplate and mask that immobilize the head, with the proton beam passing through the support and positioning assembly. It provides table support rather than delivering radiation.
Positioning Sequence
The healthcare provider first attaches the support to the couch, then places the immobilization device on it and helps the patient into position. The described support measures approximately 50.17 inches long, 21.61 inches wide and 1.62 inches high, with a weight of 68.3 pounds.
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 | Orfit Industries NV, Belgium |
|---|---|
| FDA product code | IYE |
| Device type | Accelerator, Linear, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K171734 |
| Record published | 2026-04-15 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 25000/70 | In distribution | |
| 25000/84 | In distribution | |
| 25000/89 | In distribution | |
| 25115/24MI+N/NH | In distribution | |
| 25000/75 | In distribution | |
| 25000/87 | In distribution | |
| 25000/83 | In distribution | |
| 25000/71 | In distribution | |
| 25000/7/20 | In distribution | |
| 25000/69/B | In distribution | |
| 25000/88 | In distribution | |
| 25000/61 | In distribution | |
| 25113/24MI+N/NH | 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 |
|---|---|
| K202068 | 2020-08-14 |
| K191158 | 2019-08-06 |
| K171734 | 2017-07-25 |
| K162355 | 2016-11-22 |
| K162862 | 2016-11-09 |
| K151946 | 2015-11-09 |
| K151207 | 2015-07-28 |
| K141787 | 2014-08-07 |
| K131795 | 2013-09-26 |
| K991319 | 1999-09-21 |
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.