Catalog Number

6574628

Brand Name

Q-Rad System

Version/Model Number

Q-Rad System

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 11, 2019

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K151924

Product Code

KPR

Product Code Name

System, x-ray, stationary

Public Device Record Key

ad81c8de-13b3-4d79-b504-9d77fa30065b

Public Version Date

February 12, 2019

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-