Catalog Number

-

Brand Name

Revolution

Version/Model Number

CT with Quantix Upgrade

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

K133705,K163213

Product Code

JAK

Product Code Name

System, x-ray, tomography, computed

Public Device Record Key

217c09ec-c287-46eb-ad76-040eab37d07f

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

April 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-