AccessGUDID - DEVICE: TomoTherapy® Treatment Delivery System (M65810489680)

GUDID

Device Identifier (DI) Information

Brand Name: TomoTherapy® Treatment Delivery System
Version or Model: 1048968
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N/A
Company Name: ACCURAY INCORPORATED

Primary DI Number: M65810489680
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 785961244 *Terms of Use

Device Description: Software, TomoApps, Version 2.1.1, Build # 5.1.1 (Operating Software for TomoTherapy systems, including TomoH®, TomoHD®, TomoHDA™ and Onrad™)

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?
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.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121934	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: 76bbb7e7-819c-426c-af00-13d1730fc227
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: August 25, 2017