Galaxy RTi
Galaxy RTi is a rotating gamma teletherapy system for stereotactic irradiation of structures in the adult head. It uses thirty cobalt-60 sources arranged within a shielded source carrier to…
Galaxy RTi is a rotating gamma teletherapy system for stereotactic irradiation of structures in the adult head. It uses thirty cobalt-60 sources arranged within a shielded source carrier to direct radiation beams toward a treatment target.
The system focuses the thirty beams so their doses combine at the target. Treatment delivery is automated by moving the target to the focal point while the patient’s head is immobilized in a compatible headframe fitted before treatment.
Listed Item
Image-guided radionuclide radiation therapy system for external beam radiotherapy treatment.
Positioning and Collimation
A primary collimator sits next to the source unit. An independently rotating secondary collimator provides four collimator sizes and a blocking position. The system also includes a kilovoltage X-ray positioning and verification system.
Who Else Makes It
Concentrated in Shaanxi (1), Guangdong (1), Hubei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| OUR United Corporation | Xian | Shaanxi | Contract manufacturer | 2 |
| Masep Medical Science & Technology DEVELOPMENT(SHENZHEN)Co. | Shenzhen | Guangdong | Manufacturer | 2 |
| OUR SMD Medical (Wuhan) Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 1 |
Record
| Listed by | Akesis Inc., United States |
|---|---|
| FDA product code | IWB |
| Device type | System, Radiation Therapy, Radionuclide |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5750 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K203146 |
| Record published | 2026-05-11 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Galaxy RTi | In distribution |
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| Leksell Gamma Knife Perfexion/Icon | Elekta Solutions AB | 5 |
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| GammaBeam | Best Theratronics Ltd. | 2 |
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| Isorad Detector, 15-25MV (-) 3m | Sun Nuclear Corporation | 2 |
| Leksell GammaPlan | Elekta Solutions AB | 2 |
| 15-25 MV Isorad Detector (3m Cable) | Sun Nuclear Corporation | 2 |
Showing 12 of 33. All products under System, Radiation Therapy, Radionuclide
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203146 | 2021-03-05 |
| K200050 | 2020-02-04 |
| K190844 | 2019-09-04 |
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.