TaiChiA
TaiChiA is a single-energy medical linear accelerator designed to deliver image-guided radiation therapy and radiosurgery. The filing lists 3D conformal radiotherapy, intensity-modulated…
TaiChiA is a single-energy medical linear accelerator designed to deliver image-guided radiation therapy and radiosurgery. The filing lists 3D conformal radiotherapy, intensity-modulated radiotherapy and volumetric modulated arc therapy among its treatment techniques.
The described system includes an accelerator and patient support in a radiation-shielded treatment room, with a control console in a separate control room. Its stated intended use is stereotactic radiosurgery and precision radiotherapy for conditions where radiation treatment is indicated.
Listed Item
TaiChiA Medical Linear Accelerator, has been designed to deliver radiation treatment in accordance with a prescribed plan. This system utilizes kV image guidance technology (IGRT) to deliver photon based radiation therapy treatments, using an integrated rotating linear accelerator system. TaiChiA is a single energy medical linear accelerator designed to deliver Image Guided Radiation Therapy and Radiosurgery, using 3DCRT, IMRT and VMAT techniques. It consists of the accelerator and patient support within a radiation shielded treatment room and a control console in the control room.
System Configuration
The filing describes kV image guidance for photon-based treatment and identifies TaiChiA as an integrated rotating linear accelerator system. These details describe the cleared device configuration and treatment role without extending claims to predicate or reference systems.
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 | OUR United Corporation, China |
|---|---|
| FDA product code | IYE |
| Device type | Accelerator, Linear, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K193207 |
| Record published | 2026-04-24 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TaiChiA | 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 |
|---|---|
| K210921 | 2021-11-02 |
| K193207 | 2020-08-07 |
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.