Catalog Number

-

Brand Name

HealthPNX

Version/Model Number

2.0.0

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

K190362

Product Code

QFM

Product Code Name

Radiological Computer-Assisted Prioritization Software For Lesions

Public Device Record Key

dc3eebe4-4581-49d2-b6fc-ae6e98242136

Public Version Date

March 28, 2022

Public Version Number

2

DI Record Publish Date

June 12, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-