Catalog Number

-

Brand Name

Quantaras Contour Companion

Version/Model Number

QCCv1.0.0

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 27, 2022

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K203610

Product Code

QKB

Product Code Name

Radiological Image Processing Software For Radiation Therapy

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

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-