Leksell Gamma Knife Icon
Icon Patient Cusion Klarity
3manufacturers in China registered for this device type
9catalogue numbers in this listing
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 |
| Record published | 2016-09-24 |
| Record revised | 2019-11-01 (version 5) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature -30 to 40 °C |
| Packaging | Pack of 20, pack of 10 |
| Distribution end date | 2018-10-18 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1526778 | In distribution | ||
| 1030401 | In distribution | ||
| 1526777 | In distribution | ||
| 1528948 | In distribution | ||
| 1030370 | In distribution | ||
| 1032815 | In distribution | ||
| 1075251 | In distribution | ||
| 1539744 | 10 | In distribution | |
| 1524411 | 10 | Withdrawn |
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 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 |
| 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 |
|---|---|
| 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
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.