GammaPod™ Treatment Control System
TCS Software
3manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
2recalls on this code
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 | Xcision Medical Systems, LLC, United States |
|---|---|
| FDA product code | IWB |
| Device type | System, Radiation Therapy, Radionuclide |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5750 |
| Establishment | Manufacturer |
| 510(k) | K180571 |
| Record published | 2019-03-01 |
| Record revised | 2026-04-27 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Model A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GammaPod™ Breast Immobilization and Localization System | Xcision Medical Systems, LLC | 42 |
| Extend Frame system | Elekta Instrument AB | 23 |
| Clarity® | Elekta Solutions AB | 11 |
| Leksell Gamma Knife Icon | Elekta Instrument AB | 9 |
| Leksell Gamma Knife Perfexion/Icon | Elekta Instrument AB | 9 |
| Leksell Gamma Knife Perfexion/Icon | Elekta Solutions AB | 5 |
| Leksell Gamma Knife Icon | Elekta Solutions AB | 4 |
| GammaBeam | Best Theratronics Ltd. | 2 |
| Leksell Gamma Knife C 4 4C | Elekta Instrument AB | 2 |
| 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 |
|---|---|
| K180571 | 2018-04-04 |
| K172706 | 2017-12-22 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Xcision Medical Systems, LLC | 510(k) number | 2023-11-30 | Class II | Software design | Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected | 4 units | |
| Xcision Medical Systems, LLC | 510(k) number | 2019-07-03 | Class II | Nonconforming Material/Component | One bolt on the V motor was not fully tightened which caused a drift of.13 degrees in alignment resulting in reduced dose output. | 2 | 2021-07-01 |
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.