Catalog Number

-

Brand Name

NA

Version/Model Number

1.5T EXPRESS COIL - 16E HEAD NECK ARRAY

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

K123417

Product Code

LNH

Product Code Name

System, nuclear magnetic resonance imaging

Public Device Record Key

24a2ab12-5021-4500-b0b4-29a85d32aca0

Public Version Date

October 27, 2022

Public Version Number

6

DI Record Publish Date

August 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-