Accuray Precision® Treatment Planning System

Basic Information

• Brand Name: Accuray Precision® Treatment Planning System
• Primary DI: M65810502420
• Version / Model: 1050242
• Catalog Number: NA
• Company Name: ACCURAY INCORPORATED
• Labeler DUNS: 785961244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 3
• Public Version Date: 2018-05-22
• Public Version Status: Update
• Public Device Record Key: 7c7e2f0d-c211-4ffc-9452-dc23c244b678

Device Description

Software, Version 1.0, Precision Treatment Planning System The 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MUJ	System,Planning,Radiation Therapy Treatment	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35159	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.	No	Active
40860	Radiation therapy treatment planning computer	A dedicated mainframe computer, personal computer (PC) or PC based platform and associated hardware, firmware, and operating system software used specifically to control and monitor the operation of a radiation therapy treatment planning system (RTTPS) and associated processing, display and analysis functions.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M65810502420	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]