HealthPNX
Zebra Medical Vision Ltd.HealthPNX by Zebra Medical Vision Ltd. is an AI-powered software that analyzes chest X-rays to identify suspected pneumothorax cases. It helps radiologists prioritize urgent cases by providing passive notifications on their PACS worklist, reducing triage time and potentially improving patient care efficiency. It does not modify images or provide diagnostic decisions independently but supports clinical assessment workflows.
Intended Use
A software workflow tool designed to aid clinical assessment of adult chest X-Ray cases with features suggestive of Pneumothorax in the medical care environment, providing case-level output for PACS/workstation prioritization or triage without directing attention to specific image anomalies.
Technology
HealthPNX is a radiological computer-assisted triage and notification software that automatically retrieves and processes chest X-ray studies, uses an AI algorithm to detect suspected pneumothorax findings, and provides passive notification to PACS/workstations without modifying original images or marking specific locations.
Performance
The device underwent software validation and a pivotal study with 588 chest X-ray cases, exhibiting high accuracy (AUC 98.3%, sensitivity 93.15%, specificity 92.99%) compared to ground truth annotated by radiologists. It significantly reduced triage time from 69 to 8 minutes and processed studies in an average of 22.1 seconds, demonstrating substantial equivalence to its predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/15/2019
2 months - 2
FDA Approval
5/6/2019
Other devices from Zebra Medical Vision Ltd.
- HealthPPT2021 • 510K
- HealthCCSng2021 • 510K
- HealthJOINT2020 • 510K
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