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Accuray Incorporated

United States·US-MF-000010238

Last updated September 17, 2026

Information

Country: United States
Address: 1209, Deming Way, Madison, United States
Website: accuray.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Daniel Biank
EUDAMED SRN: US-MF-000010238
FDA FEI Number: 3003873069
DUNS Number: —

Catalogue (83)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Adapt LTE Powered by Cenos	1097715-000	EUDAMED	Class I	Active
TomoTherapy Treatment Delivery System with iDMS	1068286	FDA UDI	Class II	Active
CyberKnife VSI® System	033000-000	FDA UDI	Class II	Active
Accuray Precision® Treatment Planning System	1055096	FDA UDI	Class II	Active
CyberKnife® M6™ Systems	053101-M-000	FDA UDI	Class II	Active
TomoTherapy Treatment System (Tomo HD™)	H-0000-0003	FDA UDI	Class II	Active
Accuray Precision Treatment Planning System	1070891	FDA UDI	Class II	Active
Radixact®, Treatment Delivery Console	1055487	FDA UDI	Class II	Active
iDMS™ Data Management System	1062409	FDA UDI	Class II	Active
TomoTherapy Treatment Delivery System with iDMS	1068283	FDA UDI	Class II	Active
TomoTherapy Treatment Delivery System with iDMS	1068286	FDA UDI	Class II	Active
Accuray Precision® Treatment Planning System	1061799	FDA UDI	Class II	Active
Accuray Precision® Treatment Planning System	1064270	FDA UDI	Class II	Active
CyberKnife® M6™ Systems	053401-M-000	FDA UDI	Class II	Active
Accuray Precision® Treatment Planning System	1059811	FDA UDI	Class II	Active
TomoHDA® Treatment Delivery System	1018286-000	FDA UDI	Class II	Active
CyberKnife® VSI™ Robotic Radiosurgery System	033000-000	FDA UDI	Class II	Active
CyberKnife® VSI™ System	032500-M-000	FDA UDI	Class II	Active
Radixact®, Treatment Delivery Console (TDC)	1056593	FDA UDI	Class II	Active
TomoTherapy Treatment Delivery System with iDMS	1068283	FDA UDI	Class II	Active
Delivery Analysis TM	1057375	FDA UDI	Class II	Active
Delivery Analysis TM	1052591	FDA UDI	Class II	Active
Delivery Analysis	1062213	FDA UDI	Class II	Active
Radixact™ Treatment Delivery System	1060253	FDA UDI	Class II	Active
CyberKnife® Treatment Delivery System	0660000	FDA UDI	Class II	Active
TomoH® Treatment Delivery System	1018284-000	FDA UDI	Class II	Active
CyberKnife® M6™ Systems	053201-M-000	FDA UDI	Class II	Active
Radixact Treatment Delivery System	1080200	FDA UDI	Class II	Active
CyberKnife® Treatment Delivery System	1061945	FDA UDI	Class II	Active
iDMS Data Management System	1061513	FDA UDI	Class II	Active
CyberKnife® M6™ Systems	1047641-000	FDA UDI	Class II	Active
TomoTherapy Treatment Delivery System with iDMS	1068284	FDA UDI	Class II	Active
Delivery Analysis	1064315	FDA UDI	Class II	Active
reNEW™ Certified Pre-Owned System	H-0000-0003	FDA UDI	Class II	Active
Radixact®, Treatment Delivery Console (TDC)	1057727	FDA UDI	Class II	Active
Onrad Treatment System	1049211	FDA UDI	Class II	Unknown
reNEW™ Certified Pre-Owned System	H-0000-0003	FDA UDI	Class II	Active
CyberKnife® M6™ Systems	053201-M-000	FDA UDI	Class II	Active
TomoHDA® Treatment Delivery System	1018286-000	FDA UDI	Class II	Active
TomoHD® Treatment Delivery System	1018283-000	FDA UDI	Class II	Active
CyberKnife® M6™ Systems	053301-M-000	FDA UDI	Class II	Active
Accuray Precision Treatment Planning System	1063143	FDA UDI	Class II	Active
TomoTherapy Treatment Delivery System with iDMS	1068284	FDA UDI	Class II	Active
iDMS Data Management System	1061514	FDA UDI	Class II	Active
Accuray Precision® Treatment Planning System	1050242	FDA UDI	Class II	Active
Radixact®, Treatment Delivery Console (TDC)	1050241	FDA UDI	Class II	Active
TomoHD® Treatment Delivery System	1018283-000	FDA UDI	Class II	Active
CyberKnife® Treatment Delivery System	1055810	FDA UDI	Class II	Active
CyberKnife® VSI™ Robotic Radiosurgery System Japan	032500-M-000	FDA UDI	Class II	Active
TomoTherapy Treatment Delivery System with iDMS	1062071	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (26)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 23, 2024	Z-1023-2025	—	completed	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.
Aug 3, 2023	Z-2489-2023	—	completed	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.
Feb 26, 2021	Z-1272-2021	—	terminated	The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll.
Dec 10, 2020	Z-0785-2021	—	terminated	"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
Dec 10, 2020	Z-0784-2021	—	terminated	"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
Sep 26, 2018	Z-0408-2019	—	terminated	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.
Aug 31, 2018	Z-3211-2018	—	terminated	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
Apr 10, 2018	Z-1697-2019	—	terminated	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.
Apr 10, 2018	Z-1696-2019	—	terminated	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.
Nov 17, 2017	Z-0286-2018	—	terminated	Uncontrolled couch Z-axis movement (descent)
Nov 17, 2017	Z-0289-2018	—	terminated	Uncontrolled couch Z-axis movement (descent)
Nov 17, 2017	Z-0287-2018	—	terminated	Uncontrolled couch Z-axis movement (descent)
Nov 17, 2017	Z-0288-2018	—	terminated	Uncontrolled couch Z-axis movement (descent)
Dec 6, 2016	Z-0865-2017	—	terminated	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.
Nov 22, 2016	Z-0734-2017	—	terminated	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.
Jan 22, 2016	Z-0771-2016	—	terminated	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.
Oct 31, 2014	Z-0218-2015	—	terminated	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.
Jan 13, 2014	Z-0828-2014	—	terminated	Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detaching.
Mar 27, 2013	Z-1155-2013	—	terminated	A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective.
Mar 19, 2013	Z-1126-2013	—	terminated	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.
Jan 16, 2012	Z-1098-2012	—	terminated	An anomaly was discovered during internal regression testing, where the dose information is displayed incorrectly during treatment planning during a specific workflow using the optional 4D Ray Tracing dose calculation algorithm. As a result, it is possible that the dose calculation will display a lower dose than the intended dose prescribed for treatment delivery.
Nov 7, 2011	Z-0382-2012	—	terminated	User Facility reported an anomaly where inhale and exhale CT pairs used for treatment planning did not represent the same magnitude of respiration that was displayed during treatment delivery.
Sep 12, 2011	Z-0035-2012	—	terminated	A report and investigation determined that the set screws, which were part of the retrofit of a previous recall were incorrectly engaged which allowed rotation and subsequent descent of the assembly.
Sep 12, 2011	Z-0036-2012	—	terminated	A report and investigation determined that the set screws, which were part of the retrofit of a previous recall were incorrectly engaged at one facility which allowed rotation and subsequent descent of the assembly.
Jul 13, 2011	Z-3108-2011	—	terminated	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 ROIs and dose. When the anomaly occu
Jul 7, 2011	Z-3163-2011	—	terminated	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.