Catalog Number

AD8202

Brand Name

DRX Core 4343 Detector

Version/Model Number

DRX Core 4343 Detector

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

K153142

Product Code

MQB

Product Code Name

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

Public Device Record Key

2b40ddbe-366b-4e24-ada4-b08fcf4f3348

Public Version Date

May 07, 2019

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-