Catalog Number

-

Brand Name

SICAT Air

Version/Model Number

2.0

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 07, 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

K152661

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

88a9eeff-4a77-4b37-a274-a68d584550c5

Public Version Date

August 08, 2022

Public Version Number

3

DI Record Publish Date

August 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-