AccessGUDID - DEVICE: Acuity iX Radiation Therapy Simulation System (00856545006003)

GUDID

Device Identifier (DI) Information

Brand Name: Acuity iX Radiation Therapy Simulation System
Version or Model: 15.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TM60010004
Company Name: VARIAN MEDICAL SYSTEMS, INC.

Primary DI Number: 00856545006003
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009120817 *Terms of Use

Device Description: No description.

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):	No
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?
35294	Radiation therapy simulation system	An assembly of diagnostic and radiation therapy devices comprising a radiation therapy simulation system intended for radiation therapy treatment planning applications. It is configured as a diagnostic x-ray system, e.g., fluoroscopic, planar, computed tomography (CT) with associated hardware and software. It is used to localize the field volume to be exposed during radiation therapy and to confirm the position and size of the therapeutic irradiation field produced by a specific set of treatment parameters that have been developed. A radiation therapy treatment planning system (RTTPS) will typically interface to receive the parameters being measured for further use in treatment calculations.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPQ	System, simulation, radiation therapy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K033339	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: e617965b-d7fa-459e-a397-c1d9aaf1e312
Public Version Date: September 28, 2020
Public Version Number: 1
DI Record Publish Date: September 20, 2020