Catalog Number

-

Brand Name

HealthICH

Version/Model Number

2.0.5

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K190424

Product Code

QAS

Product Code Name

Radiological Computer-Assisted Triage And Notification Software

Public Device Record Key

b0fb01b8-75c6-45d1-9381-935967da5483

Public Version Date

March 28, 2022

Public Version Number

3

DI Record Publish Date

July 02, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-