AccessGUDID - DEVICE: Quantaras Contour Companion (00860006956004)

GUDID

Device Identifier (DI) Information

Brand Name: Quantaras Contour Companion
Version or Model: QCCv1.0.0
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Quantitative Radiology Solutions LLC

Primary DI Number: 00860006956004
Issuing Agency: GS1
Commercial Distribution End Date: January 27, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 079089213 *Terms of Use

Device Description: Automatic contouring for radiation treatment planning.

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
QKB	Radiological Image Processing Software For Radiation Therapy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K203610	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: 614d6a38-672c-41ae-a40c-14eaaf4a404e
Public Version Date: March 11, 2022
Public Version Number: 2
DI Record Publish Date: September 27, 2021