Catalog Number

1019405

Brand Name

DRX-Revolution Mobile X-ray System

Version/Model Number

DRX-Revolution Mobile X-ray System

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 28, 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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K120062

Product Code

IZL

Product Code Name

System, x-ray, mobile

Public Device Record Key

140fa5ac-96a9-45eb-b8d0-487064bed6d8

Public Version Date

December 02, 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

-