# K190362: HealthPNX

- Pathway: 510(k) (Traditional)
- Applicant: Zebra Medical Vision, Ltd.
- Decided: May 6, 2019 after 80 days
- Product code: QFM (Radiological Computer-Assisted Prioritization Software For Lesions)
- Device class: 2
- Regulation: 21 CFR 892.2080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN170073 (2018). 2 ancestors in all.
23 later devices descend from it; 6 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183285: cmTriage, Curemetrix, Inc. (2019). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K192320: HealthCXR (2019), 9 descendants of its own
- K183182: Critical Care Suite (2019), 8 descendants of its own
- K211733: Lunit INSIGHT CXR Triage (2021), 7 descendants of its own
- K191556: Red Dot (2020), 6 descendants of its own
- K213941: Annalise Enterprise CXR Triage Pneumothorax (2022), 3 descendants of its own

## Indications for use
The Zebra Pneumothorax device is a software workflow tool designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of Pneumothorax in the medical care environment. HealthPNX analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. HealthPNX is not intended to direct attention to specific portions or anomalies of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out Pneumothorax or otherwise preclude clinical assessment of X-Ray cases.

Source page: https://510kreport.com/device/K190362
Methodology: https://510kreport.com/methodology