Varian AI Segmentation
2 catalogue numbers from 1.0, listed by Varian Medical Systems, Inc, United States, under System, Planning, Radiation Therapy Treatment. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
2catalogue numbers in this listing
33510(k) clearances naming this product code
25recalls on this code
Who Else Makes It
Concentrated in Jiangsu (2), Fujian (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Manteia Technologies Co., Ltd. | Xiamen | Fujian | Manufacturer | 3 |
| Masep Medical Science & Technology DEVELOPMENT(SHENZHEN)Co. | Shenzhen | Guangdong | Manufacturer | 2 |
| Suzhou Linatech Medical Science AND Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
| Varian Medical Systems China Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | Varian Medical Systems, Inc, United States |
|---|---|
| FDA product code | MUJ |
| Device type | System, Planning, Radiation Therapy Treatment |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K203469 |
| Record published | 2021-06-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1.0 | In distribution | |
| 1.1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RayStation | RaySearch Laboratories AB (publ) | 29 |
| System, Planning, Radiation Therapy Treatment | Nucletron B.V. | 17 |
| Panther TPS | Prowess, Inc. | 14 |
| RayCare | RaySearch Laboratories AB (publ) | 12 |
| Accuray Precision® Treatment Planning System | Accuray Incorporated | 7 |
| Monaco | Elekta Inc. | 7 |
| Eclipse Treatment Planning System for External Beam Radiation Therapy | Varian Medical Systems, Inc | 6 |
| syngo.via RT Image Suite | Siemens Healthcare Limited | 5 |
| Eclipse Treatment Planning System | Varian Medical Systems, Inc | 5 |
| Corvus 09 | Best Nomos | 4 |
| Monaco | Elekta Solutions AB | 4 |
| XKnife® | Integra Lifesciences Corporation | 4 |
Showing 12 of 98. All products under System, Planning, Radiation Therapy Treatment
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260750 | 2026-07-08 |
| K252304 | 2026-03-18 |
| K242463 | 2024-12-13 |
| K242378 | 2024-12-11 |
| K241876 | 2024-10-23 |
| K232400 | 2023-09-08 |
| K230557 | 2023-05-26 |
| K211881 | 2021-09-02 |
| K203469 | 2021-04-19 |
| K203766 | 2021-02-12 |
| K201607 | 2020-07-10 |
| K200608 | 2020-04-03 |
| K181145 | 2018-05-18 |
| K172163 | 2017-08-15 |
| K170969 | 2017-07-05 |
| K152393 | 2015-09-18 |
| K141248 | 2014-09-05 |
| K141283 | 2014-08-07 |
| K133247 | 2014-02-07 |
| K133331 | 2014-01-27 |
| K131891 | 2013-09-25 |
| K102011 | 2010-09-03 |
| K091492 | 2009-06-18 |
| K073020 | 2007-12-19 |
| K071760 | 2007-11-09 |
| K071873 | 2007-08-09 |
| K050296 | 2005-11-03 |
| K051497 | 2005-07-18 |
| K041403 | 2004-07-26 |
| K021268 | 2002-05-22 |
| K012017 | 2001-07-12 |
| K002312 | 2000-08-30 |
| K984532 | 1999-08-09 |
Recalls
8 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 |
|---|---|---|---|---|---|
| 2018-12-26 | Class II | Software design | There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Superposition [PCS] dose calculation algorithm. The PCS algo- rithm calculates the water equivalent range incorrectly for non-square 3D CT images ( | 1450 devices | 2021-03-10 |
| 2016-01-11 | Class II | Software design | When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments for Eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the calculated Monitor Units (MU). Potential for | 9499 | 2017-10-25 |
| 2015-09-28 | Class II | Software design (manufacturing process) | An anomaly was identified with the ARIA for Radiation Oncology software with a Clinical Assessment license. Admin Instructions may not print on drug order prescriptions or be transmitted with e-Rx. | 1971 units | 2017-05-12 |
| 2014-08-18 | Class II | Software design | Due to user error, the 4DITC can improperly allow users to clear a safety interlock imposed by the 4DITC on behalf of Varian’s Bar Code Conical Verification system from the BrainLab’s ExacTract console when it is used with BCCV. | 512 affected devices | 2015-07-30 |
| 2013-11-18 | Class II | Software design | An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and “do no clear MUs and Reference Point dose” is selected, the Monitor units may change. | 6701 | 2015-03-13 |
| 2013-01-28 | Class II | Software design | The calculation of dose dynamic plans containing different energy fields is incorrect when the Pencil Beam Convolution 11.0 algorithm (PBC 11.0) is used. | 1168 units | 2014-04-04 |
| 2012-08-17 | Class II | Software design | Varian has identified an anomaly with the Eclipse Treatment Planning where an outdated assigned Hounsfield Unit [HU] value can be used for dose calculation when the clock on the Eclipse Client Workstation is not synchronized with the Databa | 6087 | 2014-08-06 |
| 2012-06-18 | Class II | Software design (manufacturing process) | Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments) where changing the prescription in a calculated VMAT or RapidArc plan may lead to Monitor Units which do not reflect the new prescription. If | 7113 units | 2014-08-06 |
| 2012-01-30 | Not classified | Device Design | Varian has been identified an anomaly with the Eclipse Treatment Planning System where the calculated dose distribution is not updated or invalidated when a recalculation or reload is performed while the compensator or fluence editor is ope | 12,077 units ***AMENDED TO 13,527 units*** | 2014-08-15 |
| 2011-12-12 | Not classified | Software design | An anomaly has been identified with the Eclipse Treatment Planning System when planning for the Siemens Multileaf Collimator (MLC) where a virtual jaw can be positioned inside the MLC aperture and then used as the beam limiting device for t | 11807 units, ***12-12-12 Amended to: 13, 616 units*** | 2014-08-15 |
| 2011-10-31 | Not classified | Device Design | An anomaly has been identified with Varian Eclipse and RT Chart where adding a reference point in RT Chart and editing the field dose contributions may change the Prescribed Dose Per Fraction in Eclipse. | 2014-06-06 | |
| 2011-07-07 | Not classified | Software design | An anomaly has been identified in the 4D Structure Merge option of certain versions of Varian’s Eclipse Treatment Planning System. The treatment field energy may change from the current selection to a previous selection without user interve | 2014-04-04 | |
| 2011-06-30 | Not classified | Software design | In affected Eclipse versions, the treatment field energy may change from the current selection to a previous selection without use intervention and without invalidating the MU or calculated dose distribution. | 2436 | 2014-05-09 |
| 2011-05-20 | Not classified | Software design | A software anomaly has been identified with the Eclipse Monte Carlo (eMC) algorithm where not-equidistant data points in the open beam profile used during configuration may lead to inaccurate results. | 10,356 | 2012-07-13 |
| 2011-05-13 | Not classified | Software design | In affected Eclipse versions, user editing of the MLC Leaf positions may not automatically invalidate calculated dose distributions. | 10,097***12-12-12 AMENDED TO: 10664 units*** | 2014-08-15 |
| 2011-05-03 | Not classified | Software design | In affected Analytical Anisotropy Algorithm versions when modeling the second source, the collimator jaw positions are read from the first control point of the field. This can cause the delivered dose to be higher than planned locally by up | 5201 units ***12-12-12 AMENDED TO: 5448 units*** | 2014-07-09 |
| 2011-04-04 | Not classified | Software design | An anomaly in Eclipse Treatment Planning System, versions 8.0 to 8.6, whereby Actual SSD (source surface distance) value may not correspond to the Planned SSD value after Planning Approval. | 5288 units | 2012-06-27 |
| 2010-08-11 | Not classified | Software design | Medical device for brachytherapy treatment may cause users to enter incorrect syntax and lead to potential misinterpretation of patient treatment plan. | 1252 units | 2011-11-25 |
| 2010-05-13 | Not classified | Software design | Incorrect treatment plan or record: A software design deficiency has the potential for corrupted treatment plan records or treatment records in cases where multiple users editing a record simultaneously can result in a corrupted (but access | 2417 units***12-20-12 AMENDED TO: 49 units*** | 2012-02-24 |
| 2009-12-09 | Not classified | Software design | Potential for misdelivery of treatment– When preparing a treatment plan involving a split, the device may calculate excessive or insufficient monitor units for the treatment plan. | 3177 unit | 2012-02-24 |
| 2009-07-17 | Not classified | Software design | Software Issue/Mistreatment Potential– Due to software issues, dose distribution may be incorrect and unintended radiation doses may be delivered. | 1 | 2010-11-27 |
| 2008-10-02 | Not classified | Software design | When using the multiple static segment option, the device may alter dose delivery. | 64 units | 2010-11-27 |
| 2008-02-13 | Not classified | Software design | A software error causes the wedge accessory calculation to be ignored in the radiotherapy treatment plan. | 90 units | 2011-05-17 |
| 2004-06-24 | Not classified | Other | a malfunction in the software of the VARiS versions 6.2.27 and 6.2.35 which is used to set up radiation therapy devices which will reset parameters to null for future treatments if a patient receives treatment on a non-varian machine and a | 28 units | 2004-12-23 |
| 0010-08-17 | Not classified | Software design | Possible incorrect dose calculation: An anomaly in certain Eclipse versions where, under certain specific sequences of user actions, the dose distribution may fail to be re-calculated even though changes have been made which affect dose. | 7019 | 2011-07-21 |
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.