FDA.reportPublic FDA data

Accuray Precision® Treatment Planning System

Primary DI
M65810502420
Brand
Accuray Precision® Treatment Planning System
Company
ACCURAY INCORPORATED
Model
1050242
Catalog number
NA
Device description
Software, Version 1.0, Precision Treatment Planning SystemThe Accuray Precision Treatment Planning System is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery.
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUJSystem,Planning,Radiation Therapy Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUJSystem, Planning, Radiation Therapy TreatmentRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M65810502420PrimaryHIBCC0

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.

Contacts#

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

Regulatory Flags#

DUNS number
785961244
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
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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
00811376030474TomoH® Treatment Delivery System1018284-000NA2022-01-04
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

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