Accuray Incorporated
FDA Regulatory Profile
Accuray Incorporated appears in FDA public data with 22 recalls, 21 510(k) clearances, 9 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2640-2026, Class II) was initiated on June 16, 2026. Its most recent 510(k) clearance was granted on June 23, 2023.
Summary
- Total Recalls
- 22
- 510(k) Clearances
- 21
- Inspections
- 9
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2640-2026 | Class II | Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Acc | June 16, 2026 |
| Z-2644-2026 | Class II | Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Acc | June 16, 2026 |
| Z-1023-2025 | Class II | CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKn | December 23, 2024 |
| Z-2489-2023 | Class II | Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment | August 3, 2023 |
| Z-1272-2021 | Class II | CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radios | February 26, 2021 |
| Z-0784-2021 | Class II | TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and prec | December 10, 2020 |
| Z-0785-2021 | Class II | TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for th | December 10, 2020 |
| Z-0408-2019 | Class II | CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment plan | September 26, 2018 |
| Z-3211-2018 | Class II | Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate Cyber | August 31, 2018 |
| Z-1696-2019 | Class II | CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: Cybe | April 10, 2018 |
| Z-1697-2019 | Class II | CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for | April 10, 2018 |
| Z-0289-2018 | Class II | TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is inten | November 17, 2017 |
| Z-0287-2018 | Class II | TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy treatment system is intend | November 17, 2017 |
| Z-0286-2018 | Class II | Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment system is int | November 17, 2017 |
| Z-0288-2018 | Class II | TomoH(R) System, Model Number 1018284 Product Usage: The TomoTherapy treatment system is intende | November 17, 2017 |
| Z-0865-2017 | Class II | CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: The CyberKnife Robotic R | December 6, 2016 |
| Z-0734-2017 | Class II | CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number: 54000 UDI | November 22, 2016 |
| Z-0771-2016 | Class II | CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: | January 22, 2016 |
| Z-0218-2015 | Class II | CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. | October 31, 2014 |
| Z-0828-2014 | Class II | Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for | January 13, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K223159 | Radixact Treatment Delivery System | June 23, 2023 |
| K212794 | Accuray Precision Treatment Planning System | September 30, 2021 |
| K202412 | ClearRT Helical kVCT for the Radixact Treatment Delivery System | December 18, 2020 |
| K182687 | Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System | November 23, 2018 |
| K171837 | TomoTherapy Treatment Delivery System with iDMS | July 25, 2017 |
| K171086 | Accuray Precision Treatment Planning System | June 8, 2017 |
| K161144 | iDMS Data Management System | June 24, 2016 |
| K161136 | Precision Treatment Planning System | June 24, 2016 |
| K161146 | Radixact Treatment Delivery System | June 24, 2016 |
| K152488 | Onrad Treatment System | September 28, 2015 |
| K150873 | CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System | July 1, 2015 |
| K143269 | Delivery Analysis | April 14, 2015 |
| K122137 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM | October 26, 2012 |
| K121934 | TOMOTHERAPY TREATMENT SYSTEM | August 29, 2012 |
| K120233 | SYNCHRONY RESPIRATORY TRACKING SYSTEM | March 9, 2012 |
| K102650 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | November 17, 2010 |
| K072504 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | September 21, 2007 |
| K071531 | MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | August 22, 2007 |
| K062514 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | September 28, 2006 |
| K052325 | CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY | September 14, 2005 |