Catalog Number

-

Brand Name

Neuroreader

Version/Model Number

2.7

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 22, 2022

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

K140828,K140828

Product Code

LNH

Product Code Name

System, Nuclear Magnetic Resonance Imaging

Public Device Record Key

62118360-441f-4f0c-a430-4499c022fe03

Public Version Date

August 30, 2022

Public Version Number

1

DI Record Publish Date

August 22, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-