Catalog Number

-

Brand Name

SOMATOM go.Open Pro

Version/Model Number

11061670

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

K192061,K211373

Product Code

JAK

Product Code Name

System, x-ray, tomography, computed

Public Device Record Key

4a156e9f-1e34-417c-a1c3-7f8429a17ab2

Public Version Date

November 17, 2021

Public Version Number

4

DI Record Publish Date

December 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-