Atlas-Based Autosegmentation
Catalogue number Atlas-Based Autosegmentation, listed by Elekta 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
1catalogue number
2510(k) clearances naming this product code
40recalls 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 | Elekta Inc., United States |
|---|---|
| FDA product code | MUJ |
| Device type | System, Planning, Radiation Therapy Treatment |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2017-08-11 |
| Record revised | 2025-03-24 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
| Distribution end date | 2024-05-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Atlas-Based Autosegmentation | Withdrawn |
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 |
|---|---|
| K190178 | 2019-03-29 |
| K183037 | 2018-12-04 |
Recalls
40 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 |
|---|---|---|---|---|---|
| 2025-12-12 | Class II | Use error | Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient | ||
| 2025-12-12 | Class II | Use error | Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient | ||
| 2023-02-28 | Class II | Software design | Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation. | 2,020 units | |
| 2022-12-05 | Class II | Software design | A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling | 336 systems | |
| 2021-10-13 | Class II | Software design | Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels. | 1072 devices | |
| 2021-09-14 | Class II | Software design | Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set. | 214 units | |
| 2021-07-26 | Class II | Under Investigation by firm | If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams. | ||
| 2020-04-16 | Class II | Software design | The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose. | 96 devices | |
| 2019-11-22 | Class II | Software Design Change | Monaco is using the incorrect energy when optimizing and calculating dose. | 76 (7 US, 69 OUS) | |
| 2019-09-04 | Class II | Software design | It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation. | 30 units | |
| 2019-09-04 | Class II | Software design | It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation. | 49 units | |
| 2019-08-23 | Class II | Device Design | Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions. | 49 units | 2024-06-28 |
| 2019-07-03 | Class II | Under Investigation by firm | When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly. | 1396 units | |
| 2019-02-08 | Class II | Software design | If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should no | 14 devices | 2024-08-19 |
| 2017-09-01 | Class II | Nonconforming Material/Component | Incorrect DICOM mapping of the exported collimator or couch angles from ERGO, which would lead to incorrect rotation of the collimator or couch when using a MLC device for planning. | 182 | 2019-11-05 |
| 2017-01-10 | Class II | Other | Incorrect dose after editing beam number an wedge angle. | 1999 | 2020-08-18 |
| 2016-12-23 | Class II | Software design | Cross profile for Varian 60 degree wedge shows “horns.” | 433 | 2021-07-16 |
| 2016-12-21 | Class II | Nonconforming Material/Component | Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations. | 279 | 2021-07-16 |
| 2016-11-17 | Class II | Software design | Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm. | 2148 | 2021-12-17 |
| 2016-11-03 | Class II | Software design | Incorrect Dose when using the reset function. | 671 | 2021-07-16 |
| 2016-09-29 | Class II | Device Design | When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician’s Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is scaled incorrectly. | 365 | 2021-07-16 |
| 2016-08-18 | Class II | Unknown/Undetermined by firm | In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours are still present which would not be the | 3,012 units | 2025-02-28 |
| 2016-05-18 | Class II | Software design | When DICOM exporting a 3D Monaco plan and the “Composite Field Sequencing” (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined. | 1401 units | 2021-09-15 |
| 2015-12-18 | Class II | Software design | When using the option “Tumor Overlap Fraction” in VMAT planning it has been observed that in rare cases the system does include an organ at risk as target volume. This could result in open MLC, and open jaws in areas away from the target v | 154 | 2021-09-15 |
| 2015-10-16 | Class II | Other | Unintended update of Dose and MU and Incorrect Assignment of Bolus. | 154 | 2017-04-04 |
| 2015-09-15 | Class II | Device Design | Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities. | 154 units | 2017-04-04 |
| 2015-08-31 | Class II | Software design | Incorrect Treatment Delivery Using Third Party Fixed Wedges. | 1440 units | 2021-09-15 |
| 2015-05-21 | Class II | Other | Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series. | 351 | 2021-07-16 |
| 2014-12-19 | Class II | Software design | Incorrect CT to ED when using the Monaco Image Statistics Tool. | 907 | 2017-08-07 |
| 2014-12-19 | Class II | Other | Incorrect CT to ED when using the Monaco Image Statistics Tool. | 1354 | 2017-11-17 |
| 2014-08-18 | Class II | Software design | Incorrect Delivery of Composite VMAT Fields – When DICOM is exporting an arc plan (VMAT, Dynamic Conformal or 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatm | 928 units | 2021-09-15 |
| 2014-08-18 | Class II | Software design | When DICOM is exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan. | 554 units | 2017-08-08 |
| 2014-02-17 | Class II | Software design | Dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used with Dynamic Conformal arcs. | 1776 | 2015-07-21 |
| 2013-11-25 | Class II | Software Design Change | When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary, but the dose is not recalculated as it should be even after saving and re-opening the plan. | 13 | 2014-05-13 |
| 2013-11-25 | Class II | Software design | When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect. | 1424 | 2015-12-02 |
| 2013-07-02 | Class II | Device Design | Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values. | 45 | 2014-05-08 |
| 2013-05-22 | Class II | Labeling design | Patient needs to be positioned as indicated by the treatment plan. | 72 | 2013-12-23 |
| 2013-02-11 | Class II | Nonconforming Material/Component | The beam is displayed at the “gantry” angle, but the dose is calculated at the “rotation_start” angle. | 13 | 2014-01-21 |
| 2012-08-21 | Class II | Software design | During the planning process the beam weights can be changed by the customers. When the beam weights are changed and renumbered and this happens during the dose calculation it is possible to save and reopen the plan without any error message | 52 units | 2014-11-03 |
| 2012-06-21 | Class II | Software design | Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports. | 38 | 2014-04-01 |
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.