Catalog Number

-

Brand Name

ViewPoint

Version/Model Number

6. ver11

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

K173456

Product Code

LLZ

Product Code Name

System, image processing, radiological

Public Device Record Key

8b8f1aee-41c3-4dde-8475-d76f1ccaf304

Public Version Date

January 10, 2020

Public Version Number

2

DI Record Publish Date

August 09, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-