Catalog Number

-

Brand Name

SICAT FUNCTION

Version/Model Number

V2.0

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 02, 2021

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

K133320

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

1506c29d-04b1-47c8-90c2-44aad180dbc9

Public Version Date

July 05, 2021

Public Version Number

2

DI Record Publish Date

September 08, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-