Catalog Number

-

Brand Name

4D VIEWER - RADIOLOGY, ULTRASOUND WORKSTATION PACKAGE

Version/Model Number

USWP-100A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 06, 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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K082684

Product Code

LLZ

Product Code Name

System, image processing, radiological

Public Device Record Key

18d6d39c-357d-4f14-82e6-295e936aa80e

Public Version Date

November 06, 2019

Public Version Number

5

DI Record Publish Date

September 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-