CyberKnife® M6™ Systems
CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM) The CyberKnife M6 Systems are computer-controlled medical systems for planning and performing minimally…
CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM) The CyberKnife M6 Systems are computer-controlled medical systems for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy. They use a 6 MV linear accelerator mounted on a manipulator (robot) and a target locating subsystem to accurately deliver high-energy radiation (1000 MU/minute dose rate) to the treatment target. The target locating subsystem provides X-rays of the treatment area that lets the user know the position of the target. The CyberKnife M6 Systems use skull tracking, fiducial tracking (tracking of implanted radiographic markers), skeletal structure tracking, lung tumor tracking, Lung Optimized Treatment, and Synchrony Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The fixed, variable aperture and multileaf collimators are available as various beam-limiting secondary collimators.
8manufacturers in China registered for this device type
10catalogue numbers in this listing
19510(k) clearances naming this product code
38recalls 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 | Accuray Incorporated, United States |
|---|---|
| FDA product code | IYE |
| Device type | Accelerator, Linear, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Establishment | Manufacturer |
| 510(k) | K122137 |
| Record published | 2016-09-22 |
| Record revised | 2021-08-09 (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 |
|---|---|---|
| 053301-M-000 | In distribution | |
| 1047641-000 | In distribution | |
| 053401-M-000 | In distribution | |
| 1047641-000 | In distribution | |
| 053201-M-000 | In distribution | |
| 053101-M-000 | In distribution | |
| 053101-M-000 | In distribution | |
| 053201-M-000 | In distribution | |
| 053401-M-000 | In distribution | |
| 053301-M-000 | 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 |
|---|---|
| K223159 | 2023-06-23 |
| K212794 | 2021-09-30 |
| K202412 | 2020-12-18 |
| K182687 | 2018-11-23 |
| K171837 | 2017-07-25 |
| K171086 | 2017-06-08 |
| K161146 | 2016-06-24 |
| K161144 | 2016-06-24 |
| K150873 | 2015-07-01 |
| K122137 | 2012-10-26 |
| K121934 | 2012-08-29 |
| K120233 | 2012-03-09 |
| K102650 | 2010-11-17 |
| K091999 | 2009-09-18 |
| K072504 | 2007-09-21 |
| K071531 | 2007-08-22 |
| K041315 | 2004-06-10 |
| K020294 | 2002-04-22 |
| K011024 | 2001-08-10 |
Recalls Naming This Product
6 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 | 2018-09-26 | Class II | Process control | A robotics supplier notified Accuray of two manufacturing variations in the fastening of the in-line wrist and the casting of the wrist for the robot. The variation may result in premature failure of the component. | 93 units | 2021-05-12 |
| Accuray Incorporated | 510(k) number | 2018-04-10 | Class II | Other | There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may interrupt this operation causing the collimator housing | 68 units | 2021-04-01 |
| Accuray Incorporated | 510(k) number | 2016-11-22 | Class II | Software design | Accuray has become aware of a potential safety issue involving unexpected treatment robot motion when removing an accessory. This issue is limited to certain CyberKnife Systems with software version 1 0.6. | 40 affected devices | 2017-05-22 |
| Accuray Incorporated | 510(k) number | 2014-10-31 | Class II | Software design | Software upgrade to correct potential safety issue related to CyberKnife System that occurs when upgrading the Treatment Delivery Software for the first generation Iris Variable Aperture Collimator. | 84 devices subject to correction. | 2015-02-20 |
| Accuray Incorporated | 510(k) number | 2014-01-13 | Class II | Device Design | Potential Safety issue with Synchrony Boom Arm Mounting Assembly – one complaint of mounting assembly detaching. | 302 devices; 149 in US, 153 out of US. | 2014-11-25 |
| Accuray Incorporated | 510(k) number | 2013-03-19 | Class II | Component design/selection | A defect on the master-side connector block of the pneumatic tool changer could introduce a tilt in the collimator housings, resulting in a potential shift to the central axis of the radiation beam. The issue could pose significant clinical | 176 units | 2013-10-23 |
Recalls
18 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 |
|---|---|---|---|---|---|
| 2026-06-16 | Class II | Software design | In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collim | 48 units | |
| 2026-06-16 | Class II | Software design | In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collim | 292 units | |
| 2024-12-23 | Class II | Component design/selection | Snap rings may become partially or completed detached from the shafts within the internal mechanism. Uncontrolled rotation may occur on the left and right roll axes when the rings are removed or damaged. | 212 | |
| 2023-08-03 | Class II | Device Design | It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough clearance for service personnel to use a jib crane for moving components while servicing the system, resulting in possible injury to the | 82 | |
| 2021-02-26 | Class II | Equipment maintenance | The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll. | 243 units | 2022-06-27 |
| 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 |
| 2020-12-10 | Class II | Software Design Change | “MLC tickle error” may result in the delivered dose to effectively rotate from the planned dose. | 8 units | 2022-09-26 |
| 2018-08-31 | Class II | Nonconforming Material/Component | the Ball Cube II phantom calibration film was not manufactured within necessary dimensions and may introduce up to 0.5 mm of positional inaccuracy to the CyberKnife System | 259 units | 2020-12-16 |
| 2018-04-10 | Class II | Other | There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may interrupt this operation causing the collimator housing | 43 units | 2021-04-01 |
| 2017-11-17 | Class II | Software design | Uncontrolled couch Z-axis movement (descent) | 87 units | 2021-07-25 |
| 2017-11-17 | Class II | Software design | Uncontrolled couch Z-axis movement (descent) | 250 units | 2021-07-25 |
| 2017-11-17 | Class II | Software design | Uncontrolled couch Z-axis movement (descent) | 118 units | 2021-07-25 |
| 2017-11-17 | Class II | Software design | Uncontrolled couch Z-axis movement (descent) | 29 units | 2021-07-25 |
| 2016-12-06 | Class II | Device Design | Accuray has become aware of a potential safety issue involving the possibility of electric shock during maintenance activities from the lon Pump HV Power Supply at the back of the modulator cabinet. This issue is limited to certain G3, G4, | 115 affected devices. | 2017-06-09 |
| 2016-01-22 | Class II | Device Design | The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inverted) position. If this failure occurs the gun box may become loose and could come into contact with a patient. | 226 | 2016-10-20 |
| 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 |
| 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 |
| 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 |
| 2012-01-16 | Not classified | Software design | An anomaly was discovered during internal regression testing, where the dose information is displayed incorrectly during treatment planning during a specific workflow using the optional 4D Ray Tracing dose calculation algorithm. As a result | 207 | 2012-09-28 |
| 2011-11-07 | Not classified | Labeling design | User Facility reported an anomaly where inhale and exhale CT pairs used for treatment planning did not represent the same magnitude of respiration that was displayed during treatment delivery. | 30 | 2012-02-27 |
| 2011-09-12 | Not classified | Process control | A report and investigation determined that the set screws, which were part of the retrofit of a previous recall were incorrectly engaged which allowed rotation and subsequent descent of the assembly. | 236 total devices | 2012-02-27 |
| 2011-09-12 | Not classified | Process control | A report and investigation determined that the set screws, which were part of the retrofit of a previous recall were incorrectly engaged at one facility which allowed rotation and subsequent descent of the assembly. | 236 total devices | 2012-02-27 |
| 2010-10-28 | Not classified | Other | If users modify the dose calculation box to cover just the contoured anatomy and not the entire CT volume, dosage may not be properly calculated. | 219 units | 2011-04-01 |
| 2009-06-22 | Not classified | Software design | Targeting accuracy out of specification, Error alert does not render the system down, which may result in mistreatment in the wrong area. | 61 units | 2011-01-05 |
| 2009-03-16 | Not classified | Device Design | The product has the potential for the extension coupling of the Synchrony extension mounting hardware to become loose over time. The assembly weighs approximately 17 pounds; an unexpected contact with users or patients may result in serious | 2011-01-19 | |
| 2009-03-16 | Not classified | Device Design | The product has the potential for the extension coupling of the Synchrony extension mounting hardware to become loose over time. The assembly weighs approximately 17 pounds; an unexpected contact with users or patients may result in serious | 2011-01-19 | |
| 2008-11-14 | Not classified | Software design | System may use random incorrect data to calculate dose. Resulting dose calculation error can exceed 100% of correct dose which may lead to serious patient injury. | 4 units | 2010-12-02 |
| 2008-10-14 | Not classified | Software design | TomoTherapy Incorporated identified a potential issue with the Hi-Art system during the course of ongoing testing. The Operator Station Calibration panel provides access to view and modify machine specific configuration settings. Access | 215 | 2011-02-10 |
| 2008-09-18 | Not classified | Software design | TomoTherapy Inc. discovered an issue on the Hi-Art system during the course of ongoing testing. It has been identified that treatment plans involving very small structures (volume <2cc), reading in a high dose gradient region, may exhibit | 165 | 2011-04-19 |
| 2008-05-01 | Not classified | Software design | Couch may move unexpectedly, which may result in patient impacting the linear accelerator. | 105 units | 2010-11-30 |
| 2008-04-09 | Not classified | Software design | Sample beam data (which should not be used to treat patients) may differ from actual radiation output of an installed product, and which may be used by users. | 109 units | 2010-11-30 |
| 2008-02-22 | Not classified | Software design | Registration adjustment field numbers may appear on printed pages of the Register Tab as nonsense characters or values different than the numbers shown on the Operator Station (OS) display. Setup will move the couch to the correct offset po | 32 | 2008-12-02 |
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.