Accuray Incorporated
Medical device manufacturer in Madison, WI.
31510(k) clearances
0PMA approvals
41recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K223159 | Radixact Treatment Delivery SystemIYE · Traditional | 06/23/2023SE |
| K212794 | Accuray Precision Treatment Planning SystemIYE · Special | 09/30/2021SE |
| K202412 | ClearRT Helical kVCT for the Radixact Treatment Delivery SystemIYE · Traditional | 12/18/2020SE |
| K182687 | Motion Tracking and Compensation Feature for the Radixact Treatment Delivery SystemIYE · Traditional | 11/23/2018SE |
| K171837 | TomoTherapy Treatment Delivery System with iDMSIYE · Traditional | 07/25/2017SE |
| K171086 | Accuray Precision Treatment Planning SystemIYE · Traditional | 06/08/2017SE |
| K161146 | Radixact Treatment Delivery SystemIYE · Traditional | 06/24/2016SE |
| K161144 | iDMS Data Management SystemIYE · Traditional | 06/24/2016SE |
| K161136 | Precision Treatment Planning SystemMUJ · Traditional | 06/24/2016SE |
| K152488 | Onrad Treatment SystemMUJ · Special | 09/28/2015SE |
| K150873 | CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM SystemIYE · Traditional | 07/01/2015SE |
| K143269 | Delivery AnalysisMUJ · Traditional | 04/14/2015SE |
| K122137 | Cyberknife Robotic Radiosurgery System Cyberknife Vsi Robotic Radiosurgery SystemIYE · Traditional | 10/26/2012SE |
| K121934 | Tomotherapy Treatment SystemIYE · Traditional | 08/29/2012SE |
| K120233 | Synchrony Respiratory Tracking SystemIYE · Traditional | 03/09/2012SE |
| K102650 | Cyberknife Robotic Radiosurgery SystemIYE · Traditional | 11/17/2010SE |
| K091999 | Cyberknife Robotic Radiosurgery SystemIYE · Special | 09/18/2009SE |
| K091146 | Modification to Cyberknife Robotic Radiosurgery SystemMUJ · Special | 05/01/2009SE |
| K072504 | Cyberknife Robotic Radiosurgery SystemIYE · Special | 09/21/2007SE |
| K071531 | Modification to Cyberknife Robotic Radiosurgery SystemIYE · Traditional | 08/22/2007SE |
| K062967 | Cyberknife Robotic Radiosurgery SystemMUJ · Special | 10/30/2006SE |
| K062514 | Cyberknife Robotic Radiosurgery SystemMUJ · Special | 09/28/2006SE |
| K052325 | Cyberknife System for Stereotactic Radiosurgery/RadiotherapyMUJ · Special | 09/14/2005SE |
| K051941 | Cybernife Stereotactic Radiosurgery SystemMUJ · Special | 08/09/2005SE |
| K042146 | Robocouch Patient Support SystemJAI · Traditional | 09/17/2004SE |
| K041315 | Cyberknife System for Stereotactic Radiosurgery/RadiotherapyIYE · Special | 06/10/2004SE |
| K032345 | Cyberknife System for Sterotactic Radiosurgery/RadiotherapyMUJ · Special | 09/03/2003SE |
| K020294 | Motion TrackingIYE · Traditional | 04/22/2002SE |
| K011024 | Cyberknife SystemIYE · Traditional | 08/10/2001SE |
| K000478 | The Cyberknife System for Stereotactic Radiosurgery/ Radiotherapy V2.1IWB · Special | 04/19/2000SE |
| K984563 | The Cyberknife System for Stereotactic Radiosurgery/RadiotherapyIWB · Traditional | 07/14/1999SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2644-2026 Class II | Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator…In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion… | 06/16/2026Open, Classified |
| Z-2640-2026 Class II | Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator…In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion… | 06/16/2026Open, Classified |
| Z-1023-2025 Class II | CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled…Snap rings may become partially or completed detached from the shafts within the internal mechanism.… | 12/23/2024Completed |
| Z-2489-2023 Class II | Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the…It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough… | 08/03/2023Completed |
| Z-1272-2021 Class II | CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided…The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time… | 02/26/2021Terminated |
| Z-0785-2021 Class II | TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated…"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose. | 12/10/2020Terminated |
| Z-0784-2021 Class II | TomoTherapy Treatment System - Product Usage: used as an integrated system for the…"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose. | 12/10/2020Terminated |
| Z-0408-2019 Class II | CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for…A robotics supplier notified Accuray of two manufacturing variations in the fastening of the in-line wrist… | 09/26/2018Terminated |
| Z-3211-2018 Class II | Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to…the Ball Cube II phantom calibration film was not manufactured within necessary dimensions and may introduce… | 08/31/2018Terminated |
| Z-1697-2019 Class II | CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery…There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM)… | 04/10/2018Terminated |
| Z-1696-2019 Class II | CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b)…There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM)… | 04/10/2018Terminated |
| Z-0289-2018 Class II | TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system…Uncontrolled couch Z-axis movement (descent) | 11/17/2017Terminated |
| Z-0288-2018 Class II | TomoH(R) System, Model Number 1018284 Product Usage: The TomoTherapy treatment system is…Uncontrolled couch Z-axis movement (descent) | 11/17/2017Terminated |
| Z-0287-2018 Class II | TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy treatment system…Uncontrolled couch Z-axis movement (descent) | 11/17/2017Terminated |
| Z-0286-2018 Class II | Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment…Uncontrolled couch Z-axis movement (descent) | 11/17/2017Terminated |
| Z-0865-2017 Class II | CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: The CyberKnife…Accuray has become aware of a potential safety issue involving the possibility of electric shock during… | 12/06/2016Terminated |
| Z-0734-2017 Class II | CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number:…Accuray has become aware of a potential safety issue involving unexpected treatment robot motion when… | 11/22/2016Terminated |
| Z-0771-2016 Class II | CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package.…The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inverted)… | 01/22/2016Terminated |
| Z-0218-2015 Class II | CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture…Software upgrade to correct potential safety issue related to CyberKnife System that occurs when upgrading… | 10/31/2014Terminated |
| Z-0828-2014 Class II | Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA.…Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly… | 01/13/2014Terminated |
| Z-1155-2013 Class II | RoboCouch Patient Positioning System Product Usage: is intended for use in the support…A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the… | 03/27/2013Terminated |
| Z-1126-2013 Class II | Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical…A defect on the master-side connector block of the pneumatic tool changer could introduce a tilt in the… | 03/19/2013Terminated |
| Z-1098-2012 | CyberKnife Robotic Radiosurgery System with 4D Planning procedure option of MultiPlan…An anomaly was discovered during internal regression testing, where the dose information is displayed… | 01/16/2012Terminated |
| Z-0382-2012 | CyberKnife Robotic Radiosurgery System: Lung Optimized Treatment option. The CyberKnife…User Facility reported an anomaly where inhale and exhale CT pairs used for treatment planning did not… | 11/07/2011Terminated |
| Z-0036-2012 | CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch…A report and investigation determined that the set screws, which were part of the retrofit of a previous… | 09/12/2011Terminated |
| Z-0035-2012 | CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard…A report and investigation determined that the set screws, which were part of the retrofit of a previous… | 09/12/2011Terminated |
| Z-3108-2011 | HiArt versions 4.0.x, and HD versions 1.0.x, H-0000-0003. The TomoTherapy HI-ART System…As a result of an internal review, TomoTherapy has identified an issue with HiArt versions 4.0.x, and HD… | 07/13/2011Terminated |
| Z-3163-2011 | TomoMobile, Hi-Art System, H-0000-0003, TomoTherapy 1240 Deming Way, Madison, WI 53717…TomoTherapy Inc. is sending this Field Safety Notice to make you aware of an anomaly which may affect the… | 07/07/2011Terminated |
| Z-0714-2011 | CyberKnife Robotic Radiosurgery System, medical charged-particle radiation therapy…If users modify the dose calculation box to cover just the contoured anatomy and not the entire CT volume… | 10/28/2010Terminated |
| Z-0890-2011 | CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery…Latches responsible for securing the cover to the device may come lose if not properly secured and the cover… | 07/06/2010Terminated |
| Z-1023-2011 | Radiation therapy device. Medical charged particle radiation therapy system with…When a user modified the align center of an existing plan during the treatment planning process the… | 01/15/2010Terminated |
| Z-1008-2011 | CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery…If electron density values are left empty, the calculation of radiation dose in a patient will be modeled as… | 12/29/2009Terminated |
| Z-0853-2011 | RoboCouch Patient Support System, model number 025007, a subsystem of the Cyberknife…Mechanical Failure-- Patient Support System's table top may unexpectedly descend several inches. | 07/21/2009Terminated |
| Z-1810-2009 | CyberKnife Treatment Delivery System, a subsystem of the CyberKnife Robotic Radiosurgery…Targeting accuracy out of specification, Error alert does not render the system down, which may result in… | 06/22/2009Terminated |
| Z-0909-2011 | CyberKnife System Robotic Radiosurgery System, (Robocouch Patient positioning System)…The product has the potential for the extension coupling of the Synchrony extension mounting hardware to… | 03/16/2009Terminated |
| Z-0908-2011 | CyberKnife System Robotic Radiosurgery System, (Standard Treatment Couch) Synchrony…The product has the potential for the extension coupling of the Synchrony extension mounting hardware to… | 03/16/2009Terminated |
| Z-0629-2009 | Cyberknife Robotic Radiosurgery System. A radiation therapy device, MultiPlan (MP)…System may use random incorrect data to calculate dose. Resulting dose calculation error can exceed 100% of… | 11/14/2008Terminated |
| Z-0856-2009 | RoboCouch Patient Support System, a component of the CyberKnife Robotic Radiosurgery…Product may not be tensioned properly, potentially causing unexpected rotation or descent. | 10/30/2008Terminated |
| Z-1862-2008 | Accuracy Cyberknife Robotic Radiosurgery System, medical charged particle radiation…Couch may move unexpectedly, which may result in patient impacting the linear accelerator. | 05/01/2008Terminated |
| Z-2056-2008 | CyberKnife Robotic Radiosurgery System radiation therapy device with Multiplan treatment…Sample beam data (which should not be used to treat patients) may differ from actual radiation output of an… | 04/09/2008Terminated |
| Z-0364-2008 | Accuray, Multiplan Treatment Planning Software, Versions 2.0, 2.0.1 .6, 1.6.1, 1.6..1 or…Software problem - Sagittal, oblique or coronal sliced MR Images imported from a non-Accuray manufactured… | 03/21/2007Terminated |