Catalog Number

-

Brand Name

Neuroreader

Version/Model Number

2.4

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 14, 2020

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

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

851bcddd-2ed2-4c2a-8289-c5303b920d02

Public Version Date

June 08, 2022

Public Version Number

3

DI Record Publish Date

September 11, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-