AccessGUDID - DEVICE: Accuray Precision Treatment Planning System (00811376030092)

GUDID

Device Identifier (DI) Information

Brand Name: Accuray Precision Treatment Planning System
Version or Model: 1063143
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NA
Company Name: Accuray Incorporated

Primary DI Number: 00811376030092
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080044624 *Terms of Use

Device Description: Accuray Precision™ Treatment Planning System (Version 3.0)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40941	Radiation therapy treatment planning workstation	A freestanding image processing device that is a component of radiation therapy treatment planning configuration. It is sometimes considered to be a component of a picture archiving and communication system (PACS) or a local area network (LAN) configuration, e.g., a radiology information system (RIS) or hospital information system (HIS). It does not contain any controls for the direct operation of a radiation therapy system. It can receive and transmit data both on-line and off-line and is configured to provide the capability to remotely process, manipulate and view patient images and information used in treatment planning, record and verification.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUJ	System, Planning, Radiation Therapy Treatment
IYE	Accelerator, Linear, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171086	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1be0faee-0551-43ad-8024-5a3e3222fc35
Public Version Date: June 28, 2021
Public Version Number: 2
DI Record Publish Date: May 31, 2019