Catalog Number

Shoulder CT

Brand Name

Mimics Automatic Algorithms

Version/Model Number

Shoulder CT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

2d695780-103f-47c7-83e5-c88be4da7499

Public Version Date

October 24, 2022

Public Version Number

1

DI Record Publish Date

October 15, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-