Home GUDID M65810624240 NA
Primary DI M65810624240
Brand NA
Company ACCURAY INCORPORATED
Model 1062424
Catalog number NA
Device description Software, TomoApps, Version 5.1.3Operating Software for TomoTherapy systems (including TomoH, TomoHD, TomoHDA) and Onrad Treatment System.
Published 2018-06-27
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name IYE Accelerator, Linear, Medical MUJ System, Planning, Radiation Therapy Treatment
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IYE Accelerator, Linear, Medical Radiology 2 MUJ System, Planning, Radiation Therapy Treatment Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M65810624240 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Linear accelerator system An assembly of devices designed to produce high-energy electrons to yield high-energy x-rays used for therapeutic applications, primarily to treat cancer. It provides a uniform radiation field of uniform intensity and predictable energy level, in a beam with well defined dimensions. The principle of operation is linear acceleration of electrons by means of electromagnetic (EM) microwaves. The output is used as a treatment beam on the patient, either directly or after passing a suitable target. The system typically includes signal analysis and display devices, patient and device supports, and software.
Regulatory Flags# DUNS number 785961244 Device count 1 Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00811376030863 Adapt LTE powered by Accuray Cenos 1097715-000 2025-12-19 00811376030795 SW, Legal Labelling Install Disk, 5.1.9 1093013 2023-12-21 00811376030009 Radixact™ Treatment Delivery System 1060000 N/A 2018-01-26 M65810492110 Onrad Treatment System 1049211 NA 2018-06-22 00811376030344 TomoHD® Treatment Delivery System 1018283-000 NA 2022-01-04 00811376030368 CyberKnife® VSI™ Robotic Radiosurgery System 033000-000 NA 2022-01-04 00811376030429 CyberKnife® VSI™ Robotic Radiosurgery System Japan 032500-M-000 NA 2022-01-04 00811376030436 CyberKnife® M6™ Systems 053101-M-000 NA 2022-01-04 00811376030443 CyberKnife® M6™ Systems 053201-M-000 NA 2022-01-04 00811376030450 CyberKnife® M6™ Systems 053301-M-000 NA 2022-01-04 00811376030467 CyberKnife® M6™ Systems 053401-M-000 NA 2022-01-04 00811376030474 TomoH® Treatment Delivery System 1018284-000 NA 2022-01-04 00811376030481 TomoHDA® Treatment Delivery System 1018286-000 NA 2022-01-04 00811376030498 CyberKnife® M6™ Systems 1047641-000 NA 2022-01-04 00811376030504 TomoTherapy Treatment Delivery System with iDMS 1068283 NA 2022-01-04 00811376030511 TomoTherapy Treatment Delivery System with iDMS 1068284 NA 2022-01-04 00811376030528 TomoTherapy Treatment Delivery System with iDMS 1068286 NA 2022-01-04 00811376030351 reNEW™ Certified Pre-Owned System H-0000-0003 NA 2021-06-24 M65810182860 TomoHDA® Treatment Delivery System 1018286-000 NA 2016-09-22 M6580534010 CyberKnife® M6™ Systems 053401-M-000 NA 2016-09-22
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