Catalog Number

-

Brand Name

Neuroreader

Version/Model Number

2.2.8

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 07, 2017

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

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

71310b79-d1d4-4cec-a0c2-25b5d7d528a2

Public Version Date

December 07, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-