Novalis TX
2 catalogue numbers from 9.5, listed by Varian Medical Systems, Inc, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
2catalogue numbers in this listing
83510(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 | Varian Medical Systems, Inc, United States |
|---|---|
| FDA product code | IYE |
| Device type | Accelerator, Linear, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K181404 |
| Record published | 2018-07-31 |
| Record revised | 2023-06-20 (version 4) |
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 |
|---|---|---|
| 9.5 | In distribution | |
| 9.1 | 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 |
|---|---|
| K261856 | 2026-08-03 |
| K252977 | 2026-01-21 |
| K252919 | 2025-12-16 |
| K252948 | 2025-10-07 |
| K250099 | 2025-05-16 |
| K242957 | 2025-02-07 |
| K232923 | 2024-04-30 |
| K232870 | 2023-12-21 |
| K232113 | 2023-11-03 |
| K231317 | 2023-09-12 |
| K230576 | 2023-07-25 |
| K223839 | 2023-05-22 |
| K230699 | 2023-04-10 |
| K222941 | 2023-01-17 |
| K221408 | 2022-06-17 |
| K221448 | 2022-06-15 |
| K213977 | 2022-06-03 |
| K212294 | 2021-08-20 |
| K210835 | 2021-04-20 |
| K203669 | 2021-01-14 |
| K192377 | 2020-02-10 |
| K192968 | 2019-11-12 |
| K192424 | 2019-10-03 |
| K191761 | 2019-07-31 |
| K190137 | 2019-07-10 |
| K181404 | 2018-06-28 |
| K181032 | 2018-05-09 |
| K170570 | 2018-04-06 |
| K180586 | 2018-04-02 |
| K173838 | 2018-01-17 |
| K172013 | 2017-07-28 |
| K171733 | 2017-07-12 |
| K170817 | 2017-06-27 |
| K162472 | 2017-01-19 |
| K162476 | 2016-12-12 |
| K152761 | 2015-11-25 |
| K151882 | 2015-10-26 |
| K150706 | 2015-05-08 |
| K143224 | 2014-12-19 |
| K142560 | 2014-12-11 |
| K142268 | 2014-10-02 |
| K140528 | 2014-09-05 |
| K140823 | 2014-06-27 |
| K133572 | 2014-04-04 |
| K133227 | 2014-03-14 |
| K133240 | 2014-01-31 |
| K132705 | 2013-10-31 |
| K131807 | 2013-10-11 |
| K123788 | 2013-01-15 |
| K123291 | 2012-12-20 |
| K123137 | 2012-12-05 |
| K112778 | 2011-12-29 |
| K112839 | 2011-11-14 |
| K111106 | 2011-08-18 |
| K102024 | 2010-10-15 |
| K100890 | 2010-07-13 |
| K093967 | 2010-07-12 |
| K093527 | 2009-12-15 |
| K092871 | 2009-11-30 |
| K091209 | 2009-06-23 |
| K091132 | 2009-06-17 |
| K081188 | 2008-07-14 |
| K081036 | 2008-05-09 |
| K072916 | 2007-11-09 |
| K071992 | 2007-08-15 |
| K071360 | 2007-06-08 |
| K070094 | 2007-02-09 |
| K063270 | 2006-12-14 |
| K062618 | 2006-09-22 |
| K061140 | 2006-05-15 |
| K052391 | 2005-11-23 |
| K050479 | 2005-03-24 |
| K050442 | 2005-03-23 |
| K042956 | 2005-03-11 |
| K042720 | 2004-10-29 |
| K041519 | 2004-08-04 |
| K040192 | 2004-02-27 |
| K033343 | 2003-12-23 |
| K010975 | 2001-05-02 |
| K003636 | 2001-02-02 |
| K001643 | 2000-06-23 |
| K973889 | 1997-11-21 |
| K962950 | 1997-07-22 |
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 |
|---|---|---|---|---|---|---|---|
| Varian Medical Systems, Inc | 510(k) number | 2019-08-12 | Class II | Software Design Change | After a recent upgrade to the collimator software version 8.5, the firm became aware that the multi-leaf collimator leaves did not move during an arc treatment. The issue is related to a transient carriage primary- secondary interlock due t | 151 units | 2021-01-21 |
| Varian Medical Systems, Inc | 510(k) number | 2013-10-24 | Class II | Device Design | This correction is to notify users that a solution to a previous correction has been developed and Varians reps will be contacting locations to schedule installation. | 3,809 devices | 2016-01-13 |
Recalls
15 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 |
|---|---|---|---|---|---|
| 2018-08-20 | Class II | Software design | Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on more than one system. | 387 | 2020-08-28 |
| 2018-08-20 | Class II | Software design | Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on more than one system. | 4 | 2020-08-28 |
| 2016-12-02 | Class II | Device Design | Modifications in version 13.6MR2 for Contouring, SmartAdapt, and SmartSegmentation workspaces resulted in contours not being saved consistently in Eclipse. Treatment Planning System. The issue only occurs if certain conditions are fulfilled | 42 devices are affected | 2017-05-12 |
| 2016-09-13 | Class II | Device Design | Varian Medical Systems has received a report that a user was able to easily rotate the head frame posts when attached to the mounting cam on the metal head ring. There was no report of serious injury due to this issue | 75 devices | 2017-02-24 |
| 2016-06-23 | Class II | Software design | Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the | 21 AlignRT Plus in US, 1 International. | 2018-08-24 |
| 2016-06-23 | Class II | Software design | Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the | 166 OSMS in US, 23 OSMO – International, | 2018-08-24 |
| 2014-06-17 | Class II | Radiation Control for Health and Safety Act | Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode. | 3416 | 2018-09-20 |
| 2014-04-30 | Class II | Component change control | Varian MedicalSystems’ X-ray generator Supplier (CPI) has identified that 32 VMS150 X-ray Generators were shipped that are missing a ground wire between the EMIbraid on the induc tion assembly cable and the ground stud on the lid of the Hi | 32 units | 2015-03-16 |
| 2014-03-20 | Class II | Equipment maintenance | Varian has identified a failure with the shaft of the Type 01 elbow motor for Exact arms used in the On-Board Imager (OBI) device due to belt over-tensioning. | 2622 | 2015-05-01 |
| 2013-03-26 | Class II | Device Design | Varian has identified an anomaly with the RPM Respiratory Gating System version I.7.5 with 3D Option. While operating with the 6-dot marker block, this version of RPM Gating may produce an inverted respiratory waveform in amplitude and pha | 2508 units | 2014-07-09 |
| 2012-11-05 | Class II | Software design | Varian Medical Systems has identified an anomaly with the ARIA Oncology Information System Radiation Oncology [ARIA RO] DICOM import/export functionality where a 360 degree arc field may convert to static field during DICOM export or import | 264 units | 2014-03-03 |
| 2012-09-24 | Class II | Software design | An anomaly has been identified with the ARIA Oncology Information System Version 11 where Monitor Units of one fraction may be incorrect, when partial treatment is being continued. | 205 | 2013-12-05 |
| 2012-08-14 | Class II | Nonconforming Material/Component | Some X-jaw (lower collimator jaw) carriers were made using the incorrect metal alloy, which can cause the jaw carrier to crack. If both carriers on the same X-jaw crack, the jaw would be able to move freely in the closed direction. The pos | 221 Units | 2013-12-04 |
| 2012-07-02 | Class II | Software design | A software anomaly has been identified with the Import Export Application version 11.0 where MLC leaf positions for plans using BrainLab m3 and mMLC are incorrectly imported. | 2 Units. | 2013-07-01 |
| 2012-04-09 | Not classified | Device Design | A software anomaly has been identified in TrueBeam when using respiratory gating with patients in the prone position. The gating curve is inverted when a prone patient plan is loaded into TrueBeam. | 207 devices ***12-12-12 AMENDED TO: 216 UNITS*** | 2014-04-16 |
| 2012-04-09 | Not classified | Labeling design | Varian received a report involving a Gantry collision and is sending a notification to remind users of the collision protection tools available with TrueBeam and TrueBeam STx, including actions the operator should be aware of. | 207 devices 12/7/12 – amended to 216 devices. | 2014-04-16 |
| 2012-01-30 | Not classified | Device Design | An anomaly has been identified with the respiratory gating software of TrueBeam. When importing breath-hold gating protocols, the gating thresholds can be reset to default values, rather than retaining the thresholds established during plan | 182 units ***12-12-12 AMENDED TO: 200 units*** | 2014-04-16 |
| 2012-01-30 | Not classified | Device Design | An anomaly has been identified with the CT Localization module of the FastPlan treatment planning system. If the module reports a significant difference in tilt or spin on a slice and the use elects to “Discard” that slice, an incorrect cal | 201 | 2013-10-21 |
| 2012-01-16 | Not classified | Device Design | When using the Standard and Millennium 52-leaf MLC multi-leaf collimators for beam shaping, under specific treatment conditions, dose may be delivered outside of the intended treatment field that exceed the expected transmission dose. | 2012-07-26 | |
| 2012-01-16 | Not classified | Device Design | When using the Standard and Millennium 52-leaf MLC multi-leaf collimators for beam shaping, under specific treatment conditions, dose may be delivered outside of the intended treatment field that exceed the expected transmission dose. | 2012-07-26 | |
| 2011-12-16 | Not classified | Under Investigation by firm | Varian received customer complaints involving ARIA Oncology Information Systems, where the Planned Total Dose did not calculate correctly in Physicians Intent. It was identified that incorrect values were being stored for Planned No. Fracti | 2235 units***12-12-12 AMENDED TO: 2984 units*** | 2014-08-06 |
| 2011-12-12 | Not classified | Device Design | Varian has discovered that on 4D Integrated Treatment Console and TrueBeam, the ad-hoc CIAO(Complete Irradiated Area Outline) calculation results in the CIAO generation that is different from the CIAO in RT Chart. The 4DITC algorithm adds d | 4875 units | 2012-07-26 |
| 2011-12-12 | Not classified | Device Design | When multiple conical collimator treatment plans are scheduled to be treated in a session, the Plan Label should be displayed on the BCCV dialog box should match the Plan Label on the 4DITC. However, the name of the plan is not being update | 9 | 2013-12-05 |
| 2011-12-12 | Not classified | Device Design | When multiple conical collimator treatment plans are scheduled to be treated in a session, the Plan Label should be displayed on the BCCV dialog box should match the Plan Label on the 4DITC. However, the name of the plan is not being update | 55 | 2013-12-05 |
| 2011-11-28 | Not classified | Device Design | An event has been reported to Varian which entails excessive connector resistance, which caused the actual jaw positions to differ from the intended jaw positions without warning the operator. | 6158 units total | 2015-06-02 |
| 2011-11-28 | Not classified | Device Design | An event has been reported to Varian which entails excessive connector resistance, which caused the actual jaw positions to differ from the intended jaw positions without warning the operator. | 6158 units total | 2015-06-02 |
| 2011-11-23 | Not classified | Software design | An anomaly was discovered when using the 4DITC in combination with an R-Arm to acquire double exposure MV images. | 1486 devices | 2014-08-06 |
| 2011-11-10 | Not classified | Device Design | Failure to retract or park the Varian MLC leaves prior to use of the demountable BrainLAB m3 could result in the Varian MLC leaves interfering with the treatment field defined by the BrainLAB m3 without an interlock being asserted. | 205 units***12-12-12 AMENDED TO: 213 units*** | 2015-02-19 |
| 2011-10-04 | Not classified | Device Design | An anomaly has been identified with the Head Ring posts used by both the Optical Guidance Platform FrameArray module and the Floorstand where the head ring posts may be damaged due to excessive mechanical stress resulting in possible failur | 205 kits ( Each kit contains 4 Head Post Rings) 820 HPR’s | 2012-07-25 |
| 2011-09-09 | Not classified | Device Design | Varian has received reports in which a user has remotely rotated the gantry into contact with the couch or with the patient, in both the manual mode and the automate mode. | 5823 devices | 2012-07-24 |
| 2011-07-21 | Not classified | Pending | The 4D Integrated Treatment Console may erratically fail to load the planned physical wedge accessory without warning or notification when receiving an approved plan from the oncology information system. | 1125 | 2013-08-01 |
| 2011-07-20 | Not classified | Other | Potential for Varian Treatment application failing to load the physical wedge filter for a treatment field on a Siemens Mevatron linear accelerator. Delivery of a treatment field without the planned wedge would deliver more dose than intend | 118 | 2013-12-05 |
| 2011-06-27 | Not classified | Software design | In certain configurations, the 4DITC can interpret a RapidArc or VMAT treatment field as 3D Conformal Arc Treatment Plan. If a RapidArc or VMAT treatment field is incorrectly interpreted as Conformal Arc, the field will be delivered with a | 645 | 2013-12-05 |
| 2011-06-23 | Not classified | Software design | Varian has scheduled for an upgrade of the device from current version to 10.2. There are circumstances in which the 4DITC may be involved in a failure to correctly record treatment history information. | 2012-03-15 | |
| 2011-06-21 | Not classified | Nonconforming Material/Component | Varian has identified a software anomaly in the 3D Match environment, regarding a slight mismatch between CT image and Structures in On-Board Imager w/s. | 2268 | 2012-03-15 |
| 2011-06-06 | Not classified | Device Design | When using the HD120 Multi Leaf Collimator for beam shaping, and under specific treatment conditions, dose may be delivered outside of the intended treatment field that exceeds the expected transmission dose. | 173***12-20-12 AMENDED TO: 106 units*** | 2011-12-23 |
| 2011-05-31 | Class II | Process design | Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to about 7% before interlock occurs. At maximum asymmetry, this may result in no more th | 3943 units | 2013-05-15 |
| 2011-05-26 | Not classified | Device Design | On Varian Linear Accelerators where the customer may calibrate the collimator angle position readout in reverse, switching the 90 degree and 270 degree positions. | 5685 | 2012-07-13 |
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.