HealthCXR
Zebra Medical Vision, Ltd.HealthCXR is a software tool that uses artificial intelligence to analyze adult chest X-ray images for signs of pleural effusion, a condition where fluid accumulates around the lungs. It automatically alerts radiologists by prioritizing critical cases in their worklists, helping them to review urgent scans faster. The software operates alongside the standard care workflow and does not provide a diagnosis on its own, but assists clinicians in managing their caseload more efficiently.
Intended Use
The Zebra HealthCXR device is a software workflow tool designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of pleural effusion in the medical care environment. It analyzes cases using an artificial intelligence algorithm to identify suspected findings and makes case-level output available to a PACS/workstation for worklist prioritization or triage. It is not intended to direct attention to specific portions or anomalies of an image, nor to be used alone for clinical decision-making or to rule out pleural effusion.
Technology
HealthCXR automatically retrieves chest X-ray studies, validates the input, then uses an artificial intelligence algorithm to analyze frontal chest X-rays for suspected pleural effusion. It sends notification results to PACS/workstation or a standalone desktop application for prioritized review. It operates in parallel with standard care workflow, does not alter images, recommend treatment, or provide diagnosis, serving only as an aid for prioritizing critical cases.
Performance
Performance was validated on a retrospective cohort of 554 chest X-ray cases from US and Israel, with 276 positives and 278 negatives for pleural effusion. Ground truth was established by three board-certified radiologists. HealthCXR demonstrated an AUC of 0.9885, sensitivities of 96.74% and 93.84%, and specificities of 93.17% and 97.12% at two operating points. Mean processing time was about 20 to 28 seconds. These results show substantial equivalence to the predicate device and meet regulatory performance goals.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/26/2019
3 months - 2
FDA Approval
11/26/2019
Other devices from Zebra Medical Vision, Ltd.
- HealthPPT2021 • 510K
- HealthCCSng2021 • 510K
- HealthJOINT2020 • 510K
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