Catalog Number

08306000

Brand Name

i-CAT FLX™ imaging system

Version/Model Number

0.830.6000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 11, 2022

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

-

Product Code

OAS

Product Code Name

X-Ray, Tomography, Computed, Dental

Public Device Record Key

261af7fe-b959-41d1-8ceb-df3647f641e7

Public Version Date

August 30, 2022

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-