Catalog Number

-

Brand Name

Visia LungCAD

Version/Model Number

5.8

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

K043617

Product Code

OEB

Product Code Name

Lung Computed Tomography System, Computer-Aided Detection

Public Device Record Key

14dbb847-d383-4bd9-9dd2-300ad90063f2

Public Version Date

December 02, 2020

Public Version Number

6

DI Record Publish Date

December 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-