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Accuray Incorporated

Matched from indexed company URL: ACCURAY, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30038730693003873069Accuray Incorporated1Y2026-01-011209 DEMING WAY MADISON WI US 53717
10001235851000123585ACCURAY INCORPORATED1N2020-04-251310 CHESAPEAKE TERRACE Sunnyvale CA US 94089
30098131963003873069Accuray Incorporated1N2020-04-251240 Deming Way Madison WI US 53717

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00811376030009Radixact™ Treatment Delivery System - Radixact Treatment Delivery System4087164600webhelp@accuray.com
00811376030498CyberKnife® M6™ Systems - CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM)The CyberKnife M6 Systems are computer-controlled medical systems for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy. They use a 6 MV linear accelerator mounted on a manipulator (robot) and a target locating subsystem to accurately deliver high-energy radiation (1000 MU/minute dose rate) to the treatment target. The target locating subsystem provides X-rays of the treatment area that lets the user know the position of the target.The CyberKnife M6 Systems use skull tracking, fiducial tracking (tracking of implanted radiographic markers), skeletal structure tracking, lung tumor tracking, Lung Optimized Treatment, and Synchrony Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The fixed, variable aperture and multileaf collimators are available as various beam-limiting secondary collimators.408-716-4600webhelp@accuray.com
00811376030504TomoTherapy Treatment Delivery System with iDMS - The TomoTherapy Treatment Delivery System with iDMS is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.408-716-4600webhelp@accuray.com
00811376030511TomoTherapy Treatment Delivery System with iDMS - The TomoTherapy Treatment Delivery System with iDMS is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.408-716-4600webhelp@accuray.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2016371299949877K223159Radixact Treatment Delivery SystemIYE2023-06-23
2016371152095082K212794Accuray Precision Treatment Planning SystemIYE2021-09-30
2016381467678477K171837TomoTherapy Treatment Delivery System with iDMSIYE2017-07-25
2016371467678477K171837TomoTherapy Treatment Delivery System with iDMSIYE2017-07-25
795161313946582K171086Accuray Precision Treatment Planning SystemIYE2017-06-08
2016371313946582K171086Accuray Precision Treatment Planning SystemIYE2017-06-08
795161862703093K170788CyberKnife Treatment Delivery SystemIYE2017-04-11
2016371862703093K170788CyberKnife Treatment Delivery SystemIYE2017-04-11
2016372063859338K161146Radixact Treatment Delivery SystemIYE2016-06-24
2016382063859338K161146Radixact Treatment Delivery SystemIYE2016-06-24
795161964635918K161144iDMS Data Management SystemIYE2016-06-24
2016371964635918K161144iDMS Data Management SystemIYE2016-06-24
2016381060974642K152488Onrad Treatment SystemMUJ2015-09-28
2016371060974642K152488Onrad Treatment SystemMUJ2015-09-28
795161482688576K150873CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM SystemIYE2015-07-01
2016371482688576K150873CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM SystemIYE2015-07-01
2016371040439081K143269Delivery AnalysisMUJ2015-04-14
2016381040439081K143269Delivery AnalysisMUJ2015-04-14
2016371407798157K122137CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEMIYE2012-10-26
795161407798157K122137CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEMIYE2012-10-26
2016371703322138K121934TOMOTHERAPY TREATMENT SYSTEMIYE2012-08-29
2016381703322138K121934TOMOTHERAPY TREATMENT SYSTEMIYE2012-08-29
2016371386195661

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYE182023-06-23
MUJ42015-09-28

PMN#

GUDID#

Onrad Treatment System - The Onrad™ Treatment System is a radiation therapy system that integrates planning, dosecalculation, megavoltage CT imaging for IGRT functionality, and fixed beam (non-rotational)radiation therapy treatment capabilities into a single comprehensive system.The Onrad™ Treatment System is a prescription device. It delivers radiation in accordancewith a physician approved plan. The device does not diagnose disease, recommend treatmentregimens, or quantify treatment effectiveness. The megavoltage CT imaging functionality isnot intended for diagnostic use.

ACCURAY INCORPORATED

2018-06-22

CyberKnife® M6™ Systems - CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM)The CyberKnife M6 Systems are computer-controlled medical systems for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy. They use a 6 MV linear accelerator mounted on a manipulator (robot) and a target locating subsystem to accurately deliver high-energy radiation (1000 MU/minute dose rate) to the treatment target. The target locating subsystem provides X-rays of the treatment area that lets the user know the position of the target.The CyberKnife M6 Systems use skull tracking, fiducial tracking (tracking of implanted radiographic markers), skeletal structure tracking, lung tumor tracking, Lung Optimized Treatment, and Synchrony Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The fixed, variable aperture and multileaf collimators are available as various beam-limiting secondary collimators.

Accuray Incorporated

2022-01-04

CyberKnife® M6™ Systems - CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM)The CyberKnife M6 Systems are computer-controlled medical systems for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy. They use a 6 MV linear accelerator mounted on a manipulator (robot) and a target locating subsystem to accurately deliver high-energy radiation (1000 MU/minute dose rate) to the treatment target. The target locating subsystem provides X-rays of the treatment area that lets the user know the position of the target.The CyberKnife M6 Systems use skull tracking, fiducial tracking (tracking of implanted radiographic markers), skeletal structure tracking, lung tumor tracking, Lung Optimized Treatment, and Synchrony Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The fixed, variable aperture and multileaf collimators are available as various beam-limiting secondary collimators.

Accuray Incorporated

2022-01-04

CyberKnife® M6™ Systems - CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM)The CyberKnife M6 Systems are computer-controlled medical systems for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy. They use a 6 MV linear accelerator mounted on a manipulator (robot) and a target locating subsystem to accurately deliver high-energy radiation (1000 MU/minute dose rate) to the treatment target. The target locating subsystem provides X-rays of the treatment area that lets the user know the position of the target.The CyberKnife M6 Systems use skull tracking, fiducial tracking (tracking of implanted radiographic markers), skeletal structure tracking, lung tumor tracking, Lung Optimized Treatment, and Synchrony Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The fixed, variable aperture and multileaf collimators are available as various beam-limiting secondary collimators.

Accuray Incorporated

2022-01-04

CyberKnife® M6™ Systems - CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM)The CyberKnife M6 Systems are computer-controlled medical systems for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy. They use a 6 MV linear accelerator mounted on a manipulator (robot) and a target locating subsystem to accurately deliver high-energy radiation (1000 MU/minute dose rate) to the treatment target. The target locating subsystem provides X-rays of the treatment area that lets the user know the position of the target.The CyberKnife M6 Systems use skull tracking, fiducial tracking (tracking of implanted radiographic markers), skeletal structure tracking, lung tumor tracking, Lung Optimized Treatment, and Synchrony Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The fixed, variable aperture and multileaf collimators are available as various beam-limiting secondary collimators.

Accuray Incorporated

2022-01-04

CyberKnife® M6™ Systems - CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM)The CyberKnife M6 Systems are computer-controlled medical systems for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy. They use a 6 MV linear accelerator mounted on a manipulator (robot) and a target locating subsystem to accurately deliver high-energy radiation (1000 MU/minute dose rate) to the treatment target. The target locating subsystem provides X-rays of the treatment area that lets the user know the position of the target.The CyberKnife M6 Systems use skull tracking, fiducial tracking (tracking of implanted radiographic markers), skeletal structure tracking, lung tumor tracking, Lung Optimized Treatment, and Synchrony Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The fixed, variable aperture and multileaf collimators are available as various beam-limiting secondary collimators.

Accuray Incorporated

2022-01-04

CyberKnife® M6™ Systems - CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM)The CyberKnife M6 Systems are computer-controlled medical systems for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy. They use a 6 MV linear accelerator mounted on a manipulator (robot) and a target locating subsystem to accurately deliver high-energy radiation (1000 MU/minute dose rate) to the treatment target. The target locating subsystem provides X-rays of the treatment area that lets the user know the position of the target.The CyberKnife M6 Systems use skull tracking, fiducial tracking (tracking of implanted radiographic markers), skeletal structure tracking, lung tumor tracking, Lung Optimized Treatment, and Synchrony Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The fixed, variable aperture and multileaf collimators are available as various beam-limiting secondary collimators.

Accuray Incorporated

2016-09-22

CyberKnife® M6™ Systems - CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM)The CyberKnife M6 Systems are computer-controlled medical systems for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy. They use a 6 MV linear accelerator mounted on a manipulator (robot) and a target locating subsystem to accurately deliver high-energy radiation (1000 MU/minute dose rate) to the treatment target. The target locating subsystem provides X-rays of the treatment area that lets the user know the position of the target.The CyberKnife M6 Systems use skull tracking, fiducial tracking (tracking of implanted radiographic markers), skeletal structure tracking, lung tumor tracking, Lung Optimized Treatment, and Synchrony Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The fixed, variable aperture and multileaf collimators are available as various beam-limiting secondary collimators.

Accuray Incorporated

2016-09-22

CyberKnife® M6™ Systems - CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM)The CyberKnife M6 Systems are computer-controlled medical systems for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy. They use a 6 MV linear accelerator mounted on a manipulator (robot) and a target locating subsystem to accurately deliver high-energy radiation (1000 MU/minute dose rate) to the treatment target. The target locating subsystem provides X-rays of the treatment area that lets the user know the position of the target.The CyberKnife M6 Systems use skull tracking, fiducial tracking (tracking of implanted radiographic markers), skeletal structure tracking, lung tumor tracking, Lung Optimized Treatment, and Synchrony Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The fixed, variable aperture and multileaf collimators are available as various beam-limiting secondary collimators.

Accuray Incorporated

2016-09-22

CyberKnife® M6™ Systems - CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM)The CyberKnife M6 Systems are computer-controlled medical systems for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy. They use a 6 MV linear accelerator mounted on a manipulator (robot) and a target locating subsystem to accurately deliver high-energy radiation (1000 MU/minute dose rate) to the treatment target. The target locating subsystem provides X-rays of the treatment area that lets the user know the position of the target.The CyberKnife M6 Systems use skull tracking, fiducial tracking (tracking of implanted radiographic markers), skeletal structure tracking, lung tumor tracking, Lung Optimized Treatment, and Synchrony Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The fixed, variable aperture and multileaf collimators are available as various beam-limiting secondary collimators.

Accuray Incorporated

2016-09-22

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