| 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 |
| Z-1155-2013 | Class II | RoboCouch Patient Positioning System Product Usage: is intended for use in the support and pos | March 27, 2013 |
| Z-1126-2013 | Class II | Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle r | March 19, 2013 |