Accuray Incorporated
Madison, WI, US
Accuray Incorporated appears in FDA device records in Madison, WI. FDA records list 37 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 53 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Accuray Incorporated carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Accuray, Inc.510(k), recall
- Tomotherapy Incorporated510(k), enforcement report, recall
510(k) clearance history
FDA records hold 37 510(k) clearances for Accuray Incorporated between 1999 and 2023. The busiest year on record is 2004, with 3. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 3 |
| 2005 | 2 |
| 2006 | 3 |
| 2007 | 2 |
| 2008 | 1 |
| 2009 | 2 |
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 3 |
| 2015 | 3 |
| 2016 | 3 |
| 2017 | 2 |
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223159 | Radixact Treatment Delivery System | IYE | Substantially Equivalent | |
| K212794 | Accuray Precision Treatment Planning System | IYE | Substantially Equivalent | |
| K202412 | ClearRT Helical kVCT for the Radixact Treatment Delivery System | IYE | Substantially Equivalent | |
| K182687 | Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System | IYE | Substantially Equivalent | |
| K171837 | TomoTherapy Treatment Delivery System with iDMS | IYE | Substantially Equivalent | |
| K171086 | Accuray Precision Treatment Planning System | IYE | Substantially Equivalent | |
| K161146 | Radixact Treatment Delivery System | IYE | Substantially Equivalent | |
| K161144 | iDMS Data Management System | IYE | Substantially Equivalent | |
| K161136 | Precision Treatment Planning System | MUJ | Substantially Equivalent | |
| K152488 | Onrad Treatment System | MUJ | Substantially Equivalent | |
| K150873 | CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System | IYE | Substantially Equivalent | |
| K143269 | Delivery Analysis | MUJ | Substantially Equivalent | |
| K122137 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM | IYE | Substantially Equivalent | |
| K121934 | TOMOTHERAPY TREATMENT SYSTEM | IYE | Substantially Equivalent | |
| K120233 | SYNCHRONY RESPIRATORY TRACKING SYSTEM | IYE | Substantially Equivalent | |
| K112776 | TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER | MUJ | Substantially Equivalent | |
| K112446 | TOMOTHERAPY TREATMENT SYSTEM | MUJ | Substantially Equivalent | |
| K102650 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | IYE | Substantially Equivalent | |
| K091999 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | IYE | Substantially Equivalent | |
| K091146 | MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | MUJ | Substantially Equivalent | |
| K082005 | MODIFICATION TO HI-ART TREATMENT SYSTEM | MUJ | Substantially Equivalent | |
| K072504 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | IYE | Substantially Equivalent | |
| K071531 | MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | IYE | Substantially Equivalent | |
| K062967 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | MUJ | Substantially Equivalent | |
| K062514 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | MUJ | Substantially Equivalent | |
| K060912 | MODIFICATION TO: HI-ART SYSTEM | IYE | Substantially Equivalent | |
| K052325 | CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY | MUJ | Substantially Equivalent | |
| K051941 | CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM | MUJ | Substantially Equivalent | |
| K042739 | HI-ART SYSTEM | MUJ | Substantially Equivalent | |
| K042146 | ROBOCOUCH PATIENT SUPPORT SYSTEM | JAI | Substantially Equivalent | |
| K041315 | CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY | IYE | Substantially Equivalent | |
| K033347 | MODIFICATION TO: HI-ART SYSTEM | IYE | Substantially Equivalent | |
| K032345 | CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY | MUJ | Substantially Equivalent | |
| K020294 | MOTION TRACKING | IYE | Substantially Equivalent | |
| K011024 | CYBERKNIFE SYSTEM | IYE | Substantially Equivalent | |
| K000478 | THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1 | IWB | Substantially Equivalent | |
| K984563 | THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY | IWB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003873069 | 3003873069 | Accuray Incorporated | 1209 DEMING WAY, MADISON, WI 53717 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
Showing 25 of 53| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2644-2026 | Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator | 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 collimator may release and fall from the housing. | Class II | Open, Classified | |
| Z-2640-2026 | Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator | 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 collimator may release and fall from the housing. | Class II | Open, Classified | |
| Z-1023-2025 | 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 image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. | 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. | Class II | Completed | |
| Z-2489-2023 | Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System. | 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 service personnel. | Class II | Completed | |
| Z-1272-2021 | 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 radiation treatment is indicated. | The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll. | Class II | Terminated | |
| Z-0785-2021 | 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 radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. | "MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose. | Class II | Terminated | |
| Z-0784-2021 | 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 or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. | "MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose. | Class II | Terminated | |
| Z-0408-2019 | 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 conditions anywhere in the body when radiation treatment is indicated. | 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. | Class II | Terminated | |
| Z-3211-2018 | Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems | 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 | Class II | Terminated | |
| Z-1697-2019 | 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 | 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 to partially attach. | Class II | Terminated | |
| Z-1696-2019 | 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) 053301-010: CyberKnife M6 FIM Treatment Delivery System e) 053401-010: CyberKnife M6 FI+ Treatment Delivery System f) 053501-010: CyberKnife Matrix Tier 2 TDS | 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 to partially attach. | Class II | Terminated | |
| Z-0289-2018 | 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, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non- modulated (non-IMRT/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan. | Uncontrolled couch Z-axis movement (descent) | Class II | Terminated | |
| Z-0288-2018 | 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, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non- modulated (non-IMRT/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan. | Uncontrolled couch Z-axis movement (descent) | Class II | Terminated | |
| Z-0287-2018 | 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, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non- modulated (non-IMRT/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan. | Uncontrolled couch Z-axis movement (descent) | Class II | Terminated | |
| Z-0286-2018 | 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, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non- modulated (non-IMRT/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan. | Uncontrolled couch Z-axis movement (descent) | Class II | Terminated | |
| Z-0865-2017 | 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 precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. | 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, and VSI models of the CyberKnife Robotic Radiosurgery System. | Class II | Terminated | |
| Z-0734-2017 | 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 planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. | 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. | Class II | Terminated | |
| Z-0771-2016 | 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 stereotactic Radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. | 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. | Class II | Terminated | |
| Z-0507-2015 | TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3) | 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, without generating system interruption. | Class II | Terminated | |
| Z-0218-2015 | 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 precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. | 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. | Class II | Terminated | |
| Z-2239-2014 | TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, 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 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. | Class II | Terminated | |
| Z-2240-2014 | TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art 5.0.0 and 5.0.1). The TomoTherapy treatment system is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physicians prescribed and approved plan. | 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. | Class II | Terminated | |
| Z-0828-2014 | Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy. | Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detaching. | Class II | Terminated | |
| Z-1155-2013 | 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 precise positioning is required. | A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective. | Class II | Terminated | |
| Z-1126-2013 | 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 CyberKnife System is indicated for radiation treatment. | 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 impact to plans created using the smallest collimators. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain