Catalog Number

R2LIC-2111

Brand Name

ImageChecker CAD 10.0

Version/Model Number

10.0

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

P970058

Product Code

MYN

Product Code Name

Analyzer,medical image

Public Device Record Key

a2e42487-d03b-4e9a-8c55-d91443427e39

Public Version Date

October 05, 2022

Public Version Number

6

DI Record Publish Date

July 01, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-