Catalog Number

6455633

Brand Name

SICAT Suite

Version/Model Number

6455633

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,K152661,K180262

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

985a227d-89ee-492f-baf7-68125e755527

Public Version Date

July 05, 2021

Public Version Number

5

DI Record Publish Date

August 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-