Catalog Number

-

Brand Name

HealthPNX

Version/Model Number

1.0.6

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 01, 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

K190362

Product Code

QFM

Product Code Name

Radiological Computer-Assisted Prioritization Software For Lesions

Public Device Record Key

0a5becc9-29bb-46a5-884a-ad4afedf5ea6

Public Version Date

August 02, 2022

Public Version Number

4

DI Record Publish Date

May 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-