Catalog Number

XDFO2

Brand Name

Enterprise Imaging XERO Viewer

Version/Model Number

8.1.1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 22, 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

K143397

Product Code

LLZ

Product Code Name

System, image processing, radiological

Public Device Record Key

8e31d8c4-b97c-4d4c-b413-bb96e596072c

Public Version Date

July 23, 2019

Public Version Number

5

DI Record Publish Date

March 14, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-