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Accuray Incorporated: FDA-registered device maker in Madison, WI, United States, 7 510(k) clearances

Name: Accuray Incorporated FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Accuray Incorporated is registered with the FDA (registration 3003873069) in Madison, WI, United States. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated June 23, 2023. 24 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003873069
Address: 1209 Deming Way, Madison, WI, United States, 53717
Owner or operator: Accuray Incorporated (9005157)
Roles: Manufacturer
First device listed: July 28, 2015
Registered through: 2026
Brand names listed: Accuray Precision Treatment Planning System, Accuray Stellar (A configuration of Radixact Treatment Delivery System), Adapt LTE Powered by Accuray Cenos, CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM, CyberKnife M6, CyberKnife M6 Series (FM, FI, FI+, FIM, F Neuro), CyberKnife S7, CyberKnife Treatment Delivery System and more

Devices it lists

Device	Product code	Class	Role	Source
Accelerator, Linear, Medical	IYE	2	Manufacturer	accessdata.fda.gov
Instrument, Quality-Assurance, Radiologic	LHO	1	Manufacturer	accessdata.fda.gov
System, Planning, Radiation Therapy Treatment	MUJ	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 23, 2023	K223159	Radixact Treatment Delivery System	IYE	Substantially Equivalent	Accuray Incorporated	accessdata.fda.gov
September 30, 2021	K212794	Accuray Precision Treatment Planning System	IYE	Substantially Equivalent	Accuray Incorporated	accessdata.fda.gov
July 25, 2017	K171837	TomoTherapy Treatment Delivery System with iDMS	IYE	Substantially Equivalent	Accuray Incorporated	accessdata.fda.gov
April 11, 2017	K170788	CyberKnife Treatment Delivery System	IYE	Substantially Equivalent	Accuray Incorportaed	accessdata.fda.gov
July 1, 2015	K150873	CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System	IYE	Substantially Equivalent	Accuray Incorporated	accessdata.fda.gov
October 26, 2012	K122137	CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM	IYE	Substantially Equivalent	Accuray Incorporated	accessdata.fda.gov
August 29, 2012	K121934	TOMOTHERAPY TREATMENT SYSTEM	IYE	Substantially Equivalent	Accuray Incorporated	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 16, 2026	99083	Class II	Ongoing	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.	accessdata.fda.gov
June 16, 2026	99075	Class II	Ongoing	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.	accessdata.fda.gov
December 23, 2024	95814	Class II	Completed	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 stereotac	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.	accessdata.fda.gov
August 3, 2023	92772	Class II	Terminated	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.	accessdata.fda.gov
February 26, 2021	87439	Class II	Terminated	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 in	The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll.	accessdata.fda.gov
December 10, 2020	86993	Class II	Terminated	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 t	"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.	accessdata.fda.gov
September 26, 2018	81352	Class II	Terminated	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 th	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.	accessdata.fda.gov
August 31, 2018	80933	Class II	Terminated	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	accessdata.fda.gov
April 10, 2018	82664	Class II	Terminated	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	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.	accessdata.fda.gov
November 17, 2017	78686	Class II	Terminated	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 radiother	Uncontrolled couch Z-axis movement (descent)	accessdata.fda.gov
November 21, 2014	69854	Class II	Terminated	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.	accessdata.fda.gov
July 17, 2014	68948	Class II	Terminated	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.	accessdata.fda.gov
July 16, 2014	68960	Class II	Terminated	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 f	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.	accessdata.fda.gov
July 13, 2011	59439	Not yet classified	Terminated	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, stereotactic radiotherapy	As a result of an internal review, TomoTherapy has identified an issue with HiArt versions 4.0.x, and HD versions 1.0.x that we would like to bring to your attention. During DICOM export of plan level images with a non square exported Field of View (FOV), an anomaly in the process of squaring the plan level image may cause the image to shift with respect to	accessdata.fda.gov
July 7, 2011	59427	Not yet classified	Terminated	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 delivery of radiation thera	TomoTherapy Inc. is sending this Field Safety Notice to make you aware of an anomaly which may affect the performance of the TomoMobile Hi-Art System. TomoTherapy has discovered that when attempting to open the TomoMobile shielding doors, while the door hinges are in the locked position, the hinges may fail allowing the door to disengage from the shielding.	accessdata.fda.gov
January 26, 2011	57914	Not yet classified	Terminated	TomoTherapy Hi-ART System, Model # H-0000-0003 Intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or sterotactic radiosurgery to tumors or t	It was determined that the Treatment Planning Station (TPS) can potentially under dose.	accessdata.fda.gov
November 8, 2010	57337	Not yet classified	Terminated	ThomoTherapy Hi-Art System 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 tissu	TomoTherapy Inc. is sending this Field Safety Notice to make you aware of an anomaly which may affect the performance of the Hi-Art System and make it so the user cannot generate a Completion Procedure.	accessdata.fda.gov
June 23, 2010	56056	Not yet classified	Terminated	TomoTherapy Hi-Art System, ver. 4.0.0, 4.0.1, 4.0.2, ThomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and deliver	An issue has been identified, as a result of input received from one TomoTherapy Hi-Art Treatment System customer. With a particular workflow, the Planning Station's Draft and/or final Plan Report can provide incorrect dose statistics.	accessdata.fda.gov
February 22, 2010	56052	Not yet classified	Terminated	TomoTherapy Hi-Art System, Version 4.0.0 & 4.0.1. TomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. Intended to be used as an integrated system for planning and precise delivery of radiation therapy, stereotac	In some cases, the patient's diagnostic CT image is narrower than the Hi-Art radiotherapy couch image.	accessdata.fda.gov
December 1, 2009	56166	Not yet classified	Terminated	Hi-Art System, H-0000-0003 Usage: The TomoTherapy Hi-Art System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radios	An issue was identified with the TomoTherapy HI-Art System. In the event a patient or DQA plan has a moved image, roll adjustments applied during registration will be incorrect. The Planning Station Plan Settings and DQA Setup tabs allow for images to be moved during planning. During registration when roll is applied on moved images, the Operator Station inc	accessdata.fda.gov
August 10, 2009	52729	Not yet classified	Terminated	TomoTherapy Hi-Art System, Version 3.X ThomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and delivery of intensity	TomoTherapy received one customer report indicating that after starting a patient procedure from the Status Console, the radiation on light and the audible indicator on the Status Console came on as expected, however the Operator Station (OS) did not display the dose rate and the procedure time, or the couch position updates. Within a few minutes, the custom	accessdata.fda.gov
October 14, 2008	50147	Not yet classified	Terminated	TomoTherapy HI-ART Systems with versions 2.2.4, 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal. TomoTherapy HI-ART Systems is	TomoTherapy Incorporated identified a potential issue with the Hi-Art system during the course of ongoing testing. The Operator Station Calibration panel provides access to view and modify machine specific configuration settings. Access to these settings has always been restricted to individuals with appropriate security rights, being limited to only the "Su	accessdata.fda.gov
September 18, 2008	49607	Not yet classified	Terminated	TomoTherapy HI-ART Systems with 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal. The product is intended for use in radiation t	TomoTherapy Inc. discovered an issue on the Hi-Art system during the course of ongoing testing. It has been identified that treatment plans involving very small structures (volume <2cc), reading in a high dose gradient region, may exhibit inaccuracies with the DVH curve and the Dose Statistics for the small structures. This error can only happen if planning	accessdata.fda.gov
February 22, 2008	46965	Not yet classified	Terminated	TomoTherapy Hi-Art System with software versions 3.0 and 3.1 - Radiation Therapy System. The device is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy.	Registration adjustment field numbers may appear on printed pages of the Register Tab as nonsense characters or values different than the numbers shown on the Operator Station (OS) display. Setup will move the couch to the correct offset position. If the couch is manually adjusted to the incorrect value, the patient may not be the correct position during tre	accessdata.fda.gov

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Updated July 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.