FDA.reportPublic FDA data

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

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical
MUJSystem,Planning,Radiation Therapy Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2
MUJSystem, Planning, Radiation Therapy TreatmentRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121934000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121934000TOMOTHERAPY TREATMENT SYSTEMAccuray Incorporated2012-08-29IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M65810182840PreviousHIBCC0
00811376030474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811376030474008113760304748113760304740811376030474

GMDN Terms#

Term, Definition table
TermDefinition
Linear accelerator systemAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
408-716-4600webhelp@accuray.com

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 DIBrandModelCatalogPublished
00811376030863Adapt LTE powered by Accuray Cenos1097715-0002025-12-19
00811376030795SW, Legal Labelling Install Disk, 5.1.910930132023-12-21
00811376030009Radixact™ Treatment Delivery System1060000N/A2018-01-26
M65810492110Onrad Treatment System1049211NA2018-06-22
00811376030344TomoHD® Treatment Delivery System1018283-000NA2022-01-04
00811376030368CyberKnife® VSI™ Robotic Radiosurgery System033000-000NA2022-01-04
00811376030429CyberKnife® VSI™ Robotic Radiosurgery System Japan032500-M-000NA2022-01-04
00811376030436CyberKnife® M6™ Systems053101-M-000NA2022-01-04
00811376030443CyberKnife® M6™ Systems053201-M-000NA2022-01-04
00811376030450CyberKnife® M6™ Systems053301-M-000NA2022-01-04
00811376030467CyberKnife® M6™ Systems053401-M-000NA2022-01-04
00811376030481TomoHDA® Treatment Delivery System1018286-000NA2022-01-04
00811376030498CyberKnife® M6™ Systems1047641-000NA2022-01-04
00811376030504TomoTherapy Treatment Delivery System with iDMS1068283NA2022-01-04
00811376030511TomoTherapy Treatment Delivery System with iDMS1068284NA2022-01-04
00811376030528TomoTherapy Treatment Delivery System with iDMS1068286NA2022-01-04
00811376030351reNEW™ Certified Pre-Owned SystemH-0000-0003NA2021-06-24
M65810182860TomoHDA® Treatment Delivery System1018286-000NA2016-09-22
M6580534010CyberKnife® M6™ Systems053401-M-000NA2016-09-22
M6580531010CyberKnife® M6™ Systems053101-M-000NA2016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838123786Multimodality Simulation Workspace (MM Sim)1.0Philips Medical Systems Nederland B.V.MUJ2026-06-07
00884838123793Multimodality Simulation Workspace (MM Sim)1.0 UpgradePhilips Medical Systems Nederland B.V.MUJ2026-06-07
00841962120500Single Hand Extremity FibreplastQfixIYE2026-06-05
00841962120517Knee / Elbow Extremity FibreplastQfixIYE2026-06-05
00841962120524Foot Extremity FibreplastQfixIYE2026-06-05
00841962120531Dual Hand / Shoulder Extremity FibreplastQfixIYE2026-06-05
00841439115305MultiFix 2QfixIYE2026-06-04
00841439115312MultiFix 2 - JointGlowQfixIYE2026-06-04
00841439115329Extremity RiserQfixIYE2026-06-04
00841439115336Extremity Riser - JointGlowQfixIYE2026-06-04
00841439115343MultiFix Indexing PostQfixIYE2026-06-04
00840510401320KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401344KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401283KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401290KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401306KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401313KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401337KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00859032007316Panther TPSProwess, Inc.MUJ2026-06-01
00859032007323Panther TPSProwess, Inc.MUJ2026-06-01
00859032007330Panther OISProwess, Inc.MUJ2026-06-01
00859032007347Panther TPSProwess, Inc.MUJ2026-06-01
00859032007354Panther OISProwess, Inc.MUJ2026-06-01
00840510401276KLARITY MEDICALKlarity Medical Products, LLCIYE2026-05-29
08057014731224LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08057014731231LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.IYE2026-04-23
08720168162564DSPS-Prominent® Cradle-IIMACROMEDICS B.V.IYE2026-04-22
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.IYE2026-04-22