SW, Legal Labelling Install Disk, 5.1.9
Catalogue number 1093013, listed by Accuray Incorporated, 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
9510(k) clearances naming this product code
12recalls 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 | Accuray Incorporated, United States |
|---|---|
| FDA product code | MUJ |
| Device type | System, Planning, Radiation Therapy Treatment |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Establishment | Manufacturer |
| 510(k) | K121934 |
| Record published | 2023-12-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1093013 | 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 |
|---|---|
| K161136 | 2016-06-24 |
| K152488 | 2015-09-28 |
| K143269 | 2015-04-14 |
| K091146 | 2009-05-01 |
| K062967 | 2006-10-30 |
| K062514 | 2006-09-28 |
| K052325 | 2005-09-14 |
| K051941 | 2005-08-09 |
| K032345 | 2003-09-03 |
Recalls Naming This Product
8 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 |
|---|---|---|---|---|---|---|---|
| Accuray Incorporated | 510(k) number | 2020-12-10 | Class II | Software Design Change | “MLC tickle error” may result in the delivered dose to effectively rotate from the planned dose. | 7 units | 2022-09-26 |
| Accuray Incorporated | 510(k) number | 2017-11-17 | Class II | Software design | Uncontrolled couch Z-axis movement (descent) | 250 units | 2021-07-25 |
| Accuray Incorporated | 510(k) number | 2017-11-17 | Class II | Software design | Uncontrolled couch Z-axis movement (descent) | 118 units | 2021-07-25 |
| Accuray Incorporated | 510(k) number | 2017-11-17 | Class II | Software design | Uncontrolled couch Z-axis movement (descent) | 29 units | 2021-07-25 |
| Accuray Incorporated | 510(k) number | 2017-11-17 | Class II | Software design | Uncontrolled couch Z-axis movement (descent) | 87 units | 2021-07-25 |
| Accuray Incorporated | 510(k) number | 2014-11-21 | Class II | Software design | Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a failure to monitor the jaw position after a jaw error occurs. This may result in an incorrect jaw position during treatment, witho | 210 ( 72 USA; 138 OUS ) | 2015-07-17 |
| Accuray Incorporated | 510(k) number | 2014-07-17 | Class II | Software design | Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art 4.2.0, 4.2.1 and 4.2.2). Accuray has identified potential safety issues (anomalies) with these software versions. | 322 | 2015-09-08 |
| Accuray Incorporated | 510(k) number | 2014-07-16 | Class II | Software design | Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 (Hi-Art 5.0.0 and 5.0.1). Accuray has identified potential safety issues (anomalies) with these software versions. | 168 (75 US; 93 OUS) | 2015-07-21 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-07-13 | Not classified | Software design | As a result of an internal review, TomoTherapy has identified an issue with HiArt versions 4.0.x, and HD versions 1.0.x that we would like to bring to your attention. During DICOM export of plan level images with a non square exported Fiel | 346 | 2014-03-18 |
| 2011-07-07 | Not classified | Device Design | TomoTherapy Inc. is sending this Field Safety Notice to make you aware of an anomaly which may affect the performance of the TomoMobile Hi-Art System. TomoTherapy has discovered that when attempting to open the TomoMobile shielding doors, | 4 | 2012-06-29 |
| 2011-01-26 | Not classified | Software design | It was determined that the Treatment Planning Station (TPS) can potentially under dose. | 326 | 2014-03-18 |
| 2010-11-08 | Not classified | Software design | TomoTherapy Inc. is sending this Field Safety Notice to make you aware of an anomaly which may affect the performance of the Hi-Art System and make it so the user cannot generate a Completion Procedure. | 40 (21US; 19 OUS) | 2012-02-04 |
| 2010-07-06 | Not classified | Device Design | Latches responsible for securing the cover to the device may come lose if not properly secured and the cover may unexpectedly drop off. A design change is planned. | 207 units | 2011-10-04 |
| 2010-06-23 | Not classified | Software design | An issue has been identified, as a result of input received from one TomoTherapy Hi-Art Treatment System customer. With a particular workflow, the Planning Station’s Draft and/or final Plan Report can provide incorrect dose statistics. | 29 | 2011-12-17 |
| 2010-02-22 | Not classified | Software design | In some cases, the patient’s diagnostic CT image is narrower than the Hi-Art radiotherapy couch image. | 7 | 2011-02-10 |
| 2010-01-15 | Not classified | Software design | When a user modified the align center of an existing plan during the treatment planning process the effective depths of each beam in the plan were not updated by the system. These depths were incorrect and led to an incorrect dose calculati | 99 units | 2011-02-11 |
| 2009-12-29 | Not classified | Employee error | If electron density values are left empty, the calculation of radiation dose in a patient will be modeled as air-like density material rather than correct density. A plan may be created and saved, thus creating the risk of mistreatment. | 71 units are subject to this action | 2011-02-11 |
| 2009-12-01 | Not classified | Software design | An issue was identified with the TomoTherapy HI-Art System. In the event a patient or DQA plan has a moved image, roll adjustments applied during registration will be incorrect. The Planning Station Plan Settings and DQA Setup tabs al | 1 | 2011-12-17 |
| 2009-08-10 | Not classified | Software design | TomoTherapy received one customer report indicating that after starting a patient procedure from the Status Console, the radiation on light and the audible indicator on the Status Console came on as expected, however the Operator Station (O | 259 (169 US; 91 OUS) | 2011-12-17 |
| 2007-03-21 | Not classified | Software design | Software problem – Sagittal, oblique or coronal sliced MR Images imported from a non-Accuray manufactured device into the product may result in inverted image orientation. | 25 units | 2007-12-26 |
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.