Accelerator, Linear, Medical
Elekta Medical Linear Accelerator
8manufacturers in China registered for this device type
20catalogue numbers in this listing
19510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (2), Beijing (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Tian Hong Medical Technology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 4 |
| Klarity Medical & Equipment (GZ) Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 3 |
| Elekta Beijing Medical Systems Co., Ltd. | Beijing | Beijing | Contract manufacturer | 1 |
| Manteia Technologies Co., Ltd. | Xiamen | Fujian | Manufacturer | 3 |
| OUR United Corporation | Xian | Shaanxi | Contract manufacturer | 2 |
| Suzhou Linatech Medical Science AND Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
| Varian Medical Systems China Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Jiangsu Rayer Medical Technology Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Elekta Inc., United States |
|---|---|
| FDA product code | IYE |
| Device type | Accelerator, Linear, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K051932 |
| 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 | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1525332 | In distribution | |
| 1525384 | In distribution | |
| 1525333 | In distribution | |
| 1525387 | In distribution | |
| 1525325 | In distribution | |
| 1525342 | In distribution | |
| 1525343 | In distribution | |
| 1525345 | In distribution | |
| 1525339 | In distribution | |
| 1525337 | In distribution | |
| 1525331 | In distribution | |
| 1525340 | In distribution | |
| 1525717 | In distribution | |
| 1525385 | In distribution | |
| 1525338 | In distribution | |
| 1525330 | In distribution | |
| 1525341 | In distribution | |
| 1525344 | In distribution | |
| 1525326 | In distribution | |
| 1525386 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Klarity Medical | Klarity Medical Products, LLC | 891 |
| Orfit Industries | Orfit Industries NV | 680 |
| Aquaplast RT™ | Qfix | 569 |
| Fibreplast® | Qfix | 271 |
| Bionix Radiation Therapy | Bionix Radiation Therapy, LLC | 115 |
| Vac-Lok™ Cushion | Medtec LLC | 100 |
| Visicoil | IZI Medical Products LLC | 86 |
| BodyFIX | 3C-Medical Intelligence GmbH | 84 |
| AlignRT Plus | Vision RT Limited | 72 |
| Fibreplast® Assure™ Open View | Qfix | 72 |
| Accelerator, Linear, Medical | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 71 |
| Thermoplastic Mask | IZI Medical Products LLC | 58 |
Showing 12 of 1,611. All products under Accelerator, Linear, Medical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210500 | 2021-06-11 |
| K192482 | 2019-12-05 |
| K192242 | 2019-11-22 |
| K182076 | 2018-12-04 |
| K183034 | 2018-12-04 |
| K153011 | 2015-12-11 |
| K141855 | 2014-10-08 |
| K131965 | 2013-09-25 |
| K123808 | 2013-04-04 |
| K121663 | 2012-12-05 |
| K121328 | 2012-06-12 |
| K111332 | 2012-01-30 |
| K112613 | 2011-12-16 |
| K102200 | 2010-11-04 |
| K100115 | 2010-03-10 |
| K082122 | 2008-08-29 |
| K080585 | 2008-06-11 |
| K051932 | 2005-08-12 |
| K042794 | 2005-01-31 |
Recalls Naming This Product
13 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 | 2017-12-01 | Class II | Component design/selection | There is a potential for an uncontrolled extension of iViewGT / XVI detector arms. | 2,998 | 2019-11-05 |
| Elekta Inc. | 510(k) number | 2016-07-08 | Class II | Other | There have been instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts. | 553 | 2017-11-24 |
| Elekta Inc. | 510(k) number | 2015-01-07 | Class II | Other | Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail. | 46 | 2016-04-14 |
| Elekta Inc. | 510(k) number | 2013-11-25 | Class II | Software design | Potential collision risk when using XVI and external beam shaping devices. | 312 | 2016-12-14 |
| Elekta Inc. | 510(k) number | 2013-05-28 | Class II | Device Design | Customers are resetting the default values outside recommended factory settings. | 472 units | 2021-09-15 |
| Elekta Inc. | 510(k) number | 2012-12-19 | Class II | Software design | The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name. | 164 | 2021-07-14 |
| Elekta Inc. | 510(k) number | 2012-08-06 | Class II | Nonconforming Material/Component | There have been a small number of instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts. | 110 | 2014-10-08 |
| Elekta Inc. | 510(k) number | 2011-03-09 | Not classified | Software design | If “Confirm” or “Unconfirm” settings are clicked during the “Terminated Checking” phase of treatment delivery, Desktop Pro cancels the loaded beam and sets the Beam MUs to zero. Desktop Pro then sends the delivered MUs to MOSAIQ a a zero v | 56 | 2012-08-09 |
| Elekta Inc. | 510(k) number | 2011-01-05 | Not classified | Other | Flexmap calibration did not cover the full 360 degrees of gantry rotation (0 to 355 degrees) and that this caused an isocenter displacement with 2D PlanarView images required at 180 to -180. | 223 units | 2011-04-07 |
| Elekta Inc. | 510(k) number | 2010-10-25 | Not classified | Other | If another patient is selected on the imaging system (XVI) release 4.5) during the transmission of end of treatment data from Desktop Pro R7.01 to R&V system, the XVI information is prioritized and the end of treatment data is never receive | 13 units | 2011-05-24 |
| Elekta Inc. | 510(k) number | 2010-09-01 | Not classified | Other | It is possible to do couch corrections twice if both Couch Move Assistant in MOSAIQ and Remote Automatic Table in XVI are configured when in SYNERGISTIQ mode. | 23 units | 2010-12-14 |
| Elekta Inc. | 510(k) number | 2008-12-12 | Not classified | Software design | It is possible that two (or more) CT reference data sets are necessary for one patient, for example, if you have to scan a patient during breath hold and then again during free breathing. | 76 units | 2010-12-28 |
| Elekta Inc. | 510(k) number | 2007-09-19 | Not classified | Device Design | Firm became aware of a failure in the position detection system which could result in incorrect positioning of the detector in the longitudinal or lateral direction. | 166 units | 2012-08-09 |
Recalls
38 of these are 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 | Closed |
|---|---|---|---|---|---|
| 2026-05-21 | Class II | Software design | Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs. | 12 programs | |
| 2025-12-14 | Class II | Process control | Due to a manufacturing issue and electrical grounding of systems. | 5391 | |
| 2025-12-10 | Class II | Software change control | Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followe | 1 | |
| 2025-01-15 | Class II | Software design | Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale. | 64 units | |
| 2023-10-25 | Class II | Under Investigation by firm | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncont | 291 units | |
| 2023-10-25 | Class II | Under Investigation by firm | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncont | 264 units | |
| 2023-10-25 | Class II | Under Investigation by firm | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncont | 1019 units | |
| 2023-10-25 | Class II | Under Investigation by firm | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncont | 47 units | |
| 2023-10-25 | Class II | Under Investigation by firm | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncont | 451 units | |
| 2023-10-25 | Class II | Under Investigation by firm | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncont | 315 units | |
| 2023-05-05 | Class II | Under Investigation by firm | A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601 | 46 units | |
| 2023-04-06 | Class II | Process design | There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems. | 18 devices | |
| 2021-09-17 | Class II | Under Investigation by firm | There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter. | 4,405 units | 2024-09-30 |
| 2021-09-02 | Class II | Software design | A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value. | 31 | |
| 2021-04-20 | Class II | Under Investigation by firm | Malware attack | 40 units | 2023-01-17 |
| 2020-05-21 | Class II | Device Design | In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images of the monitored structure. | 26 units | 2024-08-19 |
| 2020-04-30 | Class II | Under Investigation by firm | potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray. | 32 units | 2021-08-04 |
| 2019-12-18 | Class II | Process control | There have been reports of excessive heating in the MRL Gradient Connection Module. | 21 devices | 2021-06-15 |
| 2019-06-24 | Class II | Software design | The QA software solution to perform the MR to MV alignment check, does not display the stored MR to MV offset values. The user is unable to independently inspect the values during their QA. | 12 units | 2021-04-01 |
| 2019-06-19 | Class II | Software Design Change | Potential for iGUIDE to incorrectly monitor the 3D position. | 374 devices | 2024-05-06 |
| 2019-04-03 | Class II | Labeling design | There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated. | 9 devices | 2023-05-01 |
| 2019-03-12 | Class II | Software design | Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the average position of the anatomy during the respiratory motion cycle. The images are | 12 units | 2023-11-03 |
| 2019-01-04 | Class II | Under Investigation by firm | In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and weakening of speaker fixings during the lifetime of the system, the speakers can become dislodged and be pulled into the bore. | 2 units | |
| 2018-12-13 | Class II | Software change control | There is a potential that Wedge IDs were not included in the DICOM RT PLAN sent from the TPS, which will cause the field in MOSAIQ to be created with no wedge. Treatment of a field without the planned wedge will receive more dose than the | 3,950 units total (1,747 US) | |
| 2018-12-04 | Class II | Software design | If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup field, then the copied field will have the same isocenter as the parent and that isocenter may not be the correct isocenter for imaging when it i | 551 units | 2026-02-23 |
| 2018-08-03 | Class II | Unknown/Undetermined by firm | Order Status Remains Approved When Should Indicate Complete. | 185 | 2024-09-23 |
| 2017-11-20 | Class II | Software Design Change | Potential for positional errors following automatic table movement (ATM). | 539 units total | 2024-03-15 |
| 2017-11-20 | Class II | Software Design Change | Potential for positional errors following automatic table movement (ATM). | 539 units total | 2024-03-15 |
| 2017-06-21 | Class II | Software design | Retention of Outdated Information in an Order Set. In the Care Plan Library, double clicking to add or delete a Component/Procedure to an Order Set does not trigger the update of the associated Care Plans. | 355 units | 2018-07-11 |
| 2017-06-19 | Class II | Unknown/Undetermined by firm | Incorrect PEC values. | 110 units | 2019-11-05 |
| 2016-12-02 | Class II | Software design | Edits to Particle field definition parameters may not be saved when the field definition window is saved. | 47 | 2021-11-05 |
| 2016-08-18 | Class II | Nonconforming Material/Component | Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not moved fully to the 3D position. | 13 | 2017-05-23 |
| 2016-07-15 | Class II | Software Design Change | It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order. | 383 | |
| 2016-06-17 | Class II | Software design | It is possible that that the selected Plan-of-the Day could be accidently changed by scrolling the mouse wheel up and down and inadvertently selecting another plan. | 69 | 2020-08-18 |
| 2016-05-12 | Class II | Software design | If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial s | 20 | 2021-07-16 |
| 2015-12-09 | Class II | Software design | Incorrect drug dosage due to “Age Limit” and patient weight data item issue. | 399 | 2022-09-27 |
| 2015-11-24 | Class II | Software design | First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies drugs in their database to reflect market and formulary changes. In FDB Framework v2.0, those drugs are not being included in drug-drug, drug-all | 211 | 2021-09-15 |
| 2015-07-01 | Class II | Software design | A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans using cones. | 74 Total (45 US) | 2021-09-15 |
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.