Catalog Number

-

Brand Name

MAGNETOM Skyra Fit

Version/Model Number

11516217

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

K220589

Product Code

LNH

Product Code Name

System, nuclear magnetic resonance imaging

Public Device Record Key

279f3030-ea40-4cf9-89c1-e2988bdd46f7

Public Version Date

May 27, 2022

Public Version Number

1

DI Record Publish Date

May 19, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-