Home GUDID 00811376030474 TomoH® Treatment Delivery System
Primary DI 00811376030474
Brand TomoH® Treatment Delivery System
Company Accuray Incorporated
Model 1018284-000
Catalog number NA
Device description TomoTherapy® Treatment System (H Series)
Published 2022-01-04
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 M65810182840 Previous HIBCC 0 00811376030474 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00811376030474 00811376030474 811376030474 0811376030474
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 080044624 Device count 1 DM exempt true Serial number true Manufacturing date on label true 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 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 M6580531010 CyberKnife® M6™ Systems 053101-M-000 NA 2016-09-22
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840277411815 Gold Marker RIVERPOINT MEDICAL, LLC IYE 2026-03-11 00850002461343 BiomarC® Carbon Medical Technologies, Inc. IYE 2024-07-23 00850002461350 Carbon Bright ® Carbon Medical Technologies, Inc. IYE 2024-07-23 00850016008176 VeraForm Viscus Biologics LLC IYE 2024-01-16 07340145700421 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145700445 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145700506 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145700582 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145700643 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145700667 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701060 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701084 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701107 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701121 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701145 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701169 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701183 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701206 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701220 Gold Anchor Naslund Medical AB IYE 2023-01-23 B887001062 X-MARK Ultra Izi Medical Products, LLC IYE 2022-07-18 B887001067 X-MARK Ultra Izi Medical Products, LLC IYE 2022-07-18 B8870010010 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010020 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010030 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010070 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010080 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010090 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010210 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010220 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010230 X-MARK Izi Medical Products, LLC IYE 2022-06-17
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