Company ยท US
Accuray Incorporated
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2023. Name variants (Inc, Corp, punctuation) are merged.
31510(k) clearances (0 in 12 months)
41recalls (2 in 12 months)
39recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 23, 2023 | K223159 | Radixact Treatment Delivery System Accuray Incorporated | IYE |
| Sep 30, 2021 | K212794 | Accuray Precision Treatment Planning System Accuray Incorporated | IYE |
| Dec 18, 2020 | K202412 | ClearRT Helical kVCT for the Radixact Treatment Delivery System Accuray Incorporated | IYE |
| Nov 23, 2018 | K182687 | Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System Accuray Incorporated | IYE |
| Jul 25, 2017 | K171837 | TomoTherapy Treatment Delivery System with iDMS Accuray Incorporated | IYE |
| Jun 8, 2017 | K171086 | Accuray Precision Treatment Planning System Accuray Incorporated | IYE |
| Jun 24, 2016 | K161146 | Radixact Treatment Delivery System Accuray Incorporated | IYE |
| Jun 24, 2016 | K161144 | iDMS Data Management System Accuray Incorporated | IYE |
| Jun 24, 2016 | K161136 | Precision Treatment Planning System Accuray Incorporated | MUJ |
| Sep 28, 2015 | K152488 | Onrad Treatment System Accuray Incorporated | MUJ |
| Jul 1, 2015 | K150873 | CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System Accuray Incorporated | IYE |
| Apr 14, 2015 | K143269 | Delivery Analysis Accuray Incorporated | MUJ |
| Oct 26, 2012 | K122137 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM Accuray Incorporated | IYE |
| Aug 29, 2012 | K121934 | TOMOTHERAPY TREATMENT SYSTEM Accuray Incorporated | IYE |
| Mar 9, 2012 | K120233 | SYNCHRONY RESPIRATORY TRACKING SYSTEM Accuray Incorporated | IYE |
| Nov 17, 2010 | K102650 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM Accuray Incorporated | IYE |
| Sep 18, 2009 | K091999 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM Accuray, Inc. | IYE |
| May 1, 2009 | K091146 | MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM Accuray, Inc. | MUJ |
| Sep 21, 2007 | K072504 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM Accuray Incorporated | IYE |
| Aug 22, 2007 | K071531 | MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM Accuray Incorporated | IYE |
| Oct 30, 2006 | K062967 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM Accuray, Inc. | MUJ |
| Sep 28, 2006 | K062514 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM Accuray Incorporated | MUJ |
| Sep 14, 2005 | K052325 | CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY Accuray Incorporated | MUJ |
| Aug 9, 2005 | K051941 | CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM Accuray, Inc. | MUJ |
| Sep 17, 2004 | K042146 | ROBOCOUCH PATIENT SUPPORT SYSTEM Accuray Incorporated | JAI |
| Jun 10, 2004 | K041315 | CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY Accuray, Inc. | IYE |
| Sep 3, 2003 | K032345 | CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY Accuray, Inc. | MUJ |
| Apr 22, 2002 | K020294 | MOTION TRACKING Accuray, Inc. | IYE |
| Aug 10, 2001 | K011024 | CYBERKNIFE SYSTEM Accuray, Inc. | IYE |
| Apr 19, 2000 | K000478 | THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1 Accuray, Inc. | IWB |
| Jul 14, 1999 | K984563 | THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY Accuray, Inc. | IWB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2026 | Accuray Incorporated Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator Open, Classified |
IYE | K170788 |
| Jul 1, 2026 | Accuray Incorporated Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator Open, Classified |
IYE | K170788 |
| Jan 27, 2025 | Accuray Incorporated CyberKnife Treatment Delivery System, REF 0660000
The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is indicated for i Completed |
IYE | K170788 |
| Aug 31, 2023 | Accuray Incorporated Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System. Completed |
IYE | K161146 |
| Feb 26, 2021 | Accuray Incorporated CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radia Terminated |
IYE | K170788 |
| Dec 10, 2020 | Accuray Incorporated TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic rad Terminated |
IYE | K171837 |
| Dec 10, 2020 | Accuray Incorporated TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors Terminated |
IYE | K121934 |
| Sep 26, 2018 | Accuray Incorporated CyberKnife M6, Part Number 054000-004
The CyberKnife M6 Systems are indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and con Terminated |
IYE | K150873 |
| Sep 20, 2018 | Accuray Incorporated Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E
Product is used to calibrate CyberKnife systems Terminated |
IYE | None listed |
| Apr 10, 2018 | Accuray Incorporated CyberKnife VSI, Part Numbers:
a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan
b) 033000-010: CyberKnife VSI Robotic Radiosurgery System Terminated |
IYE | None listed |
| Apr 10, 2018 | Accuray Incorporated CyberKnife M6, Part Numbers:
a) 0660000: CyberKnife Treatment Delivery System
b) 053101-010: CyberKnife M6 FI Treatment Delivery System
c) 053201-010: CyberKnife M6 FM Treatment Delivery System
d) 0 Terminated |
IYE | K150873 |
| Nov 17, 2017 | Accuray Incorporated TomoHDA(R) System, Model Number 1018286
Product Usage:
The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, ste Terminated |
IYE | K121934 |
| Nov 17, 2017 | Accuray Incorporated TomoH(R) System, Model Number 1018284
Product Usage:
The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stere Terminated |
IYE | K121934 |
| Nov 17, 2017 | Accuray Incorporated TomoHD(R) System, Model Number 1018283
Product Usage:
The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, ster Terminated |
IYE | K121934 |
| Nov 17, 2017 | Accuray Incorporated Hi-Art(R) System, Model Number H-000-0003
Product Usage:
The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, s Terminated |
IYE | K121934 |
| Dec 21, 2016 | Accuray Incorporated CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI.
Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and Terminated |
IYE | K011024 |
| Dec 12, 2016 | Accuray Incorporated CyberKnife Robotic Radiosurgery System using software version 10.6;
Catalog/Part Number: 54000
UDI: M658053301 0
Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment plann Terminated |
IYE | K122137 |
| Feb 9, 2016 | Accuray Incorporated CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package.
Product Usage:
The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereo Terminated |
IYE | K120233 |
| Nov 14, 2014 | Accuray Incorporated CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator.
The CyberKnife is indicated for treatment planning and image guided stereotactic Radiosurgery and p Terminated |
IYE | K122137 |
| Jan 27, 2014 | Accuray Incorporated Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA.
Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy. Terminated |
IYE | K122137 |
| Apr 20, 2013 | Accuray Incorporated RoboCouch Patient Positioning System
Product Usage: is intended for use in the support and positioning of a patient during radiosurgery and radiotherapy procedures and other medical procedures when Terminated |
JAI | K042146 |
| Apr 16, 2013 | Accuray Incorporated Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberK Terminated |
IYE | K122137 |
| Feb 23, 2012 | Accuray Incorporated CyberKnife Robotic Radiosurgery System with 4D Planning procedure option of MultiPlan Treatment Planning System, versions 3.0, 3.1, 3.5.1, 3.5.2 and 3.5.3 with Ray-Tracing dose calculation.
Accuray In Terminated |
IYE | K091999 |
| Jan 11, 2012 | Accuray Incorporated CyberKnife Robotic Radiosurgery System: Lung Optimized Treatment option.
The CyberKnife treatment is indicated for the treatment planning and image guided stereotactic radiosurgery and precision radi Terminated |
IYE | K091999 |
| Oct 11, 2011 | Accuray Incorporated CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch Patient Positioning System), a Radiation Therapy Device. Model Numbers: 026430, 028186.
Product is manufacture Terminated |
IYE | K102650 |
| Oct 11, 2011 | Accuray Incorporated CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch).
Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 0281 Terminated |
IYE | K102650 |
| Aug 31, 2011 | Accuray Incorporated HiArt versions 4.0.x, and HD versions 1.0.x, H-0000-0003.
The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, ster Terminated |
MUJ | K082005 |
| Jul 7, 2011 | Accuray Incorporated TomoMobile, Hi-Art System, H-0000-0003, TomoTherapy 1240 Deming Way, Madison, WI 53717
The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and precise deliv Terminated |
MUJ | K082005 |
| Feb 2, 2011 | Accuray Inc Radiation therapy device. Medical charged particle radiation therapy system with software version. Model Numbers: Multi Plan Treatment Planning System, Software version 3.0, 3.1, 3.5.0, and 3.5.1.
F Terminated |
MUJ | K091146 |
| Feb 1, 2011 | Accuray Inc CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System, with MultiPlan Treatment Planning System Software version 3.5
Medical charged-particle radiation thera Terminated |
MUJ | K091146 |
| Jan 18, 2011 | Accuray Inc CyberKnife System Robotic Radiosurgery System, (Robocouch Patient positioning System) Synchrony Respiratory Tracking System, a Radiation therapy device, Model Numbers: 026430, 028186, Product is manuf Terminated |
IYE | K020294 K072504 |
| Jan 18, 2011 | Accuray Inc CyberKnife System Robotic Radiosurgery System, (Standard Treatment Couch) Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185, Product is manufactured and Terminated |
IYE | K020294 K072504 |
| Jan 11, 2011 | Accuray Inc RoboCouch Patient Support System, model number 025007, a subsystem of the Cyberknife Robotic Radiosurgery System, manufactured by Accuray Incorporated, Sunnyvale, CA.
Intended for use in the support Terminated |
JAI | K042146 K072504 |
| Jan 10, 2011 | Accuray Inc CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System radiation therapy device, manufactured by Accuray Inc., Sunnyvale, CA.
Medical device indicated for tre Terminated |
MUJ | K091146 |
| Dec 16, 2010 | Accuray Inc CyberKnife Robotic Radiosurgery System, medical charged-particle radiation therapy system, manufactured by Accuray Inc., Sunnyvale, CA.
Indicated for treatment planning and image-guided stereotactic Terminated |
IYE | K091999 |
| Sep 14, 2009 | Accuray Inc CyberKnife Treatment Delivery System, a subsystem of the CyberKnife Robotic Radiosurgery System, manufactured by Accuray Inc., Sunnyvale, CA.
Indicated for treatment for planning and image-guided ste Terminated |
IYE | K072504 |
| Jan 17, 2009 | Accuray Inc Cyberknife Robotic Radiosurgery System. A radiation therapy device, MultiPlan (MP) Treatment Planning Software and Iris Variable Aperture Collimator, Software version 3.0.
Product is indicated for t Terminated |
IYE | K072504 |
| Jan 14, 2009 | Accuray Inc RoboCouch Patient Support System, a component of the CyberKnife Robotic Radiosurgery System. Model number 025007, manufactured by Accuray Inc., Sunnyvale, CA
The CyberKnife is indicated for treatment Terminated |
JAI | K042146 |
| Sep 17, 2008 | Accuray Inc CyberKnife Robotic Radiosurgery System radiation therapy device with Multiplan treatment Planning Software versions 1.5.2 and higher. Terminated |
IYE | K072504 |
| Sep 16, 2008 | Accuray Inc Accuracy Cyberknife Robotic Radiosurgery System, medical charged particle radiation therapy device. Model number 020700 (axum/standard treatment couch) and 021756 hand controller. The device is indi Terminated |
IYE | K072504 |
| Dec 12, 2007 | Accuray Inc Accuray, Multiplan Treatment Planning Software, Versions 2.0, 2.0.1 .6, 1.6.1, 1.6..1 or 1.6.3., Accuray, Sunnyvale, CA 94089. Terminated |
MUJ | K052325 |