Catalog Number

08306300

Brand Name

i-CAT FLX™ imaging system

Version/Model Number

0.830.6300

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

K162085,K162085

Product Code

OAS

Product Code Name

X-ray, tomography, computed, dental

Public Device Record Key

0344f96e-8a74-4ca7-8070-9650dc6e41d5

Public Version Date

August 30, 2022

Public Version Number

2

DI Record Publish Date

March 04, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-