Catalog Number

-

Brand Name

AI-Rad Companion (Cardiovascular)

Version/Model Number

11270037

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

K183268

Product Code

JAK

Product Code Name

System, x-ray, tomography, computed

Public Device Record Key

251b9cd0-260a-4d7b-96be-33a347c2a529

Public Version Date

November 17, 2021

Public Version Number

2

DI Record Publish Date

March 09, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-