Catalog Number

-

Brand Name

Lunit INSIGHT MMG

Version/Model Number

1.1

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

K211678

Product Code

QDQ

Product Code Name

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

Public Device Record Key

8921a5be-5a44-4ef4-ad46-8e4106a6b90f

Public Version Date

October 28, 2022

Public Version Number

3

DI Record Publish Date

April 28, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-