Catalog Number

8113615

Brand Name

Classic CR System

Version/Model Number

Classic CR System

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K020635

Product Code

MQB

Product Code Name

Solid state x-ray imager (flat panel/digital imager)

Public Device Record Key

7db1ffb7-bfda-4276-874e-5e09ad3622b2

Public Version Date

March 09, 2020

Public Version Number

9

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-