Leksell Gamma Knife Icon
MR Head Support Perfexion
3manufacturers in China registered for this device type
4catalogue numbers in this listing
3510(k) clearances naming this product 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 | Elekta Solutions AB, Sweden |
|---|---|
| FDA product code | IWB |
| Device type | System, Radiation Therapy, Radionuclide |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5750 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2025-06-12 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1030420 | In distribution | |
| 1016200 | In distribution | |
| 1034751 | In distribution | |
| 1515171 | 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 |
| 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 |
| Isorad Detector, 6-12MV (+) 3m | Sun Nuclear Corporation | 2 |
Showing 12 of 33. All products under System, Radiation Therapy, Radionuclide
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250391 | 2025-07-02 |
| K232854 | 2024-02-08 |
| K222047 | 2022-10-26 |
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.