Catalog Number

-

Brand Name

SecurView Diagnostic Workstation

Version/Model Number

SecurView DX

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K103385

Product Code

LLZ

Product Code Name

System, image processing, radiological

Public Device Record Key

f9ce9014-fdb2-4d56-b7bb-9cce449acb44

Public Version Date

October 05, 2022

Public Version Number

5

DI Record Publish Date

September 25, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-