Leksell Stereotactic System
Film Holder Tool
3manufacturers in China registered for this device type
1catalogue number
13510(k) clearances naming this product code
1recall
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 Instrument AB, Sweden |
|---|---|
| FDA product code | IWB |
| Device type | System, Radiation Therapy, Radionuclide |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5750 |
| 510(k) | K151159 |
| Record published | 2016-09-24 |
| Record revised | 2022-11-14 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1002964 | 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 |
|---|---|
| K173789 | 2018-03-30 |
| K173791 | 2018-02-09 |
| K160440 | 2016-04-20 |
| K151159 | 2015-10-29 |
| K151561 | 2015-08-04 |
| K133565 | 2014-05-09 |
| K120811 | 2012-05-24 |
| K092083 | 2009-09-22 |
| K063512 | 2007-03-05 |
| K061941 | 2006-08-21 |
| K061540 | 2006-07-05 |
| K051022 | 2005-06-01 |
| K984328 | 1999-05-21 |
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 |
|---|---|---|---|---|---|---|---|
| Elekta Inc. | 510(k) number | 2017-05-23 | Class II | Other | If the gantry module is replaced after original installation the configuration settings may be missing. The identified risk for this issue is electrical safety for technicians doing maintenance on the X-ray generator. | 2 | 2017-10-18 |
| Elekta Inc. | 510(k) number | 2016-04-19 | Class II | Use error | The latches of the frame adapter can be locked even if the locating pins of the frame adapter is not inserted into the corresponding holes in the coordinate frame. | 217 | 2021-07-16 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2018-06-27 | Class II | Software design | The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume. | 52 devices |
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.