Accuray Incorporated

FDA Registration(s)#

GUDID Contact Samples#

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

• accuray.com

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• Radixact Treatment Delivery System

  2023-06-23

  Accuray Incorporated

• Accuray Precision Treatment Planning System

  2021-09-30

  Accuray Incorporated

• ClearRT Helical KVCT For The Radixact Treatment Delivery System

  2020-12-18

  Accuray Incorporated

• Motion Tracking And Compensation Feature For The Radixact Treatment Delivery System

  2018-11-23

  ACCURAY INCORPORATED

• TomoTherapy Treatment Delivery System With IDMS

  2017-07-25

  Accuray Incorporated

• Accuray Precision Treatment Planning System

  2017-06-08

  Accuray Incorporated

• CyberKnife Treatment Delivery System

  2017-04-11

  Accuray Incorportaed

• Precision Treatment Planning System

  2016-06-24

  ACCURAY INCORPORATED

• IDMS Data Management System

  2016-06-24

  ACCURAY INCORPORATED

• Radixact Treatment Delivery System

  2016-06-24

  ACCURAY INCORPORATED

• Onrad Treatment System

  2015-09-28

  ACCURAY INCORPORATED

• CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System

  2015-07-01

  ACCURAY INCORPORATED

• Delivery Analysis

  2015-04-14

  ACCURAY INCORPORATED

• CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM

  2012-10-26

  ACCURAY INCORPORATED

• TOMOTHERAPY TREATMENT SYSTEM

  2012-08-29

  ACCURAY INCORPORATED

• SYNCHRONY RESPIRATORY TRACKING SYSTEM

  2012-03-09

  ACCURAY INCORPORATED

• CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

  2010-11-17

  ACCURAY INCORPORATED

• CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

  2009-09-18

  Accuray, Inc.

• MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

  2009-05-01

  ACCURAY, INC.

• CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

  2007-09-21

  Accuray Incorporated

• CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

  2006-10-30

  ACCURAY, INC.

• ROBOCOUCH PATIENT SUPPORT SYSTEM

  2004-09-17

  ACCURAY INCORPORATED

• CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY

  2004-06-10

  ACCURAY, INC.

• CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY

  2003-09-03

  ACCURAY, INC.

• MOTION TRACKING

  2002-04-22

  ACCURAY, INC.

• CYBERKNIFE SYSTEM

  2001-08-10

  ACCURAY, INC.

• THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1

  2000-04-19

  ACCURAY, INC.

• THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY

  1999-07-14

  ACCURAY, INC.

GUDID#

• Adapt LTE powered by Accuray Cenos - Adapt LTE Quality Assurance Tool

  Accuray Incorporated

  2025-12-19

• SW, Legal Labelling Install Disk, 5.1.9 - TomoTherapy Treatment System (H Series)

  Accuray Incorporated

  2023-12-21

• Radixact™ Treatment Delivery System - Radixact Treatment Delivery System

  Accuray Incorporated

  2018-01-26

• 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

• TomoHD® Treatment Delivery System - TomoTherapy Treatment System (H Series)

  Accuray Incorporated

  2022-01-04

• CyberKnife® VSI™ Robotic Radiosurgery System - The CyberKnife® Treatment Delivery System (CKTDS) is a computer-controlled radiation treatment delivery system for performing minimally invasive stereotactic radiosurgery and precision radiotherapy. The CyberKnife Treatment Delivery System is intended to work with Accuray Precision® Treatment Planning System and iDMS™ Data Management System.

  Accuray Incorporated

  2022-01-04

• CyberKnife® VSI™ Robotic Radiosurgery System Japan - The CyberKnife® Treatment Delivery System (CKTDS) is a computer-controlled radiation treatment delivery system for performing minimally invasive stereotactic radiosurgery and precision radiotherapy. The CyberKnife Treatment Delivery System is intended to work with Accuray Precision® Treatment Planning System and iDMS™ Data Management System.

  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

• TomoH® Treatment Delivery System - TomoTherapy® Treatment System (H Series)

  Accuray Incorporated

  2022-01-04

• TomoHDA® Treatment Delivery System - TomoTherapy Treatment System (H Series)

  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

• TomoTherapy 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.

  Accuray Incorporated

  2022-01-04

• TomoTherapy 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.

  Accuray Incorporated

  2022-01-04

• TomoTherapy 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.

  Accuray Incorporated

  2022-01-04

• reNEW™ Certified Pre-Owned System - H-0000-0003

  Accuray Incorporated

  2021-06-24

• TomoHDA® Treatment Delivery System - TomoTherapy Treatment System (H Series)

  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

• 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® Treatment Delivery System - The CyberKnife® Treatment Delivery System (CKTDS) is a computer-controlled radiation treatment delivery system for performing minimally invasive stereotactic radiosurgery and precision radiotherapy. The CyberKnife Treatment Delivery System is intended to work with Accuray Precision® Treatment Planning System and iDMS™ Data Management System.

  Accuray Incorporated

  2018-01-26

• Accuray Precision Treatment Planning System - Accuray Precision™ Treatment Planning System (Version 3.1)

  Accuray Incorporated

  2020-04-27

• Radixact Treatment Delivery System - Radixact Treatment Delivery System, Version 2.0.(including Base System, kV, and Synchrony)

  Accuray Incorporated

  2019-05-31

• Accuray Precision Treatment Planning System - Accuray Precision™ Treatment Planning System (Version 3.0)

  Accuray Incorporated

  2019-05-31

• Accuray Precision® Treatment Planning System - 1049210-000

  Accuray Incorporated

  2020-11-03

• Delivery Analysis - Software, Delivery Analysis, Version 1.2.1

  ACCURAY INCORPORATED

  2020-02-11

• iDMS Data Management System - IDMS Data Management System (Version 3.0)

  ACCURAY INCORPORATED

  2019-05-31

• Accuray Precision® Treatment Planning System - Software, Accuray Precision Treatment Planning System, (Version 1.1.1.1)The Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.

  ACCURAY INCORPORATED

  2018-11-23

• iDMS™ Data Management System - Software, iDMS™ Data Management System, (Version 1.1.1.1)The iDMS™ Data Management System is indicated for the storage, retrieval, and processing of data utilized in the practice of radiotherapy, stereotactic radiotherapy and stereotactic radiosurgery.

  ACCURAY INCORPORATED

  2018-11-23

• TomoTherapy 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.

  ACCURAY INCORPORATED

  2018-11-02

• TomoTherapy 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.

  ACCURAY INCORPORATED

  2018-11-02

• TomoTherapy 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.

  ACCURAY INCORPORATED

  2018-10-30

• iDMS Data Management System - Software, Version 2.0, iDMS Data Management SystemThe iDMS Data Management System is indicated for the storage, retrieval, and processing of data utilized in the practice of radiotherapy, stereotactic radiotherapy and stereotactic radiosurgery.

  ACCURAY INCORPORATED

  2018-09-24

• Accuray Precision® Treatment Planning System - Software, Version 2.0, Accuray Precision Treatment Planning SystemThe Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.

  ACCURAY INCORPORATED

  2018-09-24

• Delivery Analysis - Software, Delivery Analysis, Version 1.2.2

  ACCURAY INCORPORATED

  2018-09-24

• NA - Software, TomoApps, Version 5.1.2Operating Software for TomoTherapy systems (including TomoH®, TomoHD®, TomoHDA) and Onrad Treatment System™

  ACCURAY INCORPORATED

  2018-06-27

• NA - Software, TomoApps, Version 5.1.3Operating Software for TomoTherapy systems (including TomoH, TomoHD, TomoHDA) and Onrad Treatment System.

  ACCURAY INCORPORATED

  2018-06-27

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