Catalog Number

-

Brand Name

Intuition

Version/Model Number

Intuition Mobile

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K121916,K131447

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

a4d861be-0214-4bfa-a1fd-3271f846b898

Public Version Date

August 18, 2021

Public Version Number

3

DI Record Publish Date

November 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-