Catalog Number

CMF CT

Brand Name

Mimics

Version/Model Number

CMF CT

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 15, 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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K183105

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

4e10de46-7749-418b-9706-ea6f1a2679ef

Public Version Date

October 17, 2022

Public Version Number

4

DI Record Publish Date

February 12, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-