Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K192320
    Device Name
    HealthCXR
    Manufacturer
    Zebra Medical Vision, Ltd.
    Date Cleared
    2019-11-26

    (92 days)

    Product Code
    QFM
    Regulation Number
    892.2080
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zebra Medical Vision, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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. HealthCXR analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/worldion for worklist prioritization or triage. HealthCXR 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 pleural effusion or otherwise preclude clinical assessment of X-Ray cases.
    Device Description
    The HealthCXR solution is a software product that automatically identifies suspected findings on chest x-rays (e.g. pleural effusion) and notifies PACS/workstation of the presence of this critical finding in the scan. This notification allows for worklist prioritization of the identified scan and assists clinicians in viewing the prioritized scan before others. The device aim is to aid in prioritization and triage of radiological medical images only. The software is automatic and is capable of analyzing PA or AP chest x-rays. If a suspected finding is found in a scan, the alert is automatically sent to the PACS/workstation used by the radiologist or to a standalone desktop application in parallel with the ongoing standard of care. The PACS/workstation prioritizes and displays the study through its worklist interface. The standalone desktop application, Zebra Worklist, includes a compressed preview image meant for informational purposed only and is not intended for diagnostic use. The HealthCXR device works in parallel to and in conjunction with the standard care of workflow. After a chest x-ray has been performed, a copy of the study is automatically retrieved and processed by the HealthCXR device performs the analysis of the study and returns a notification about the relevant pathology to the PACS/workstation which prioritizes it through the worklist interface or alternatively, the Zebra Worklist will notify the user through the standalone desktop application. The clinician is then able to review the study earlier than in standard of care workflow. The software does not recommend treatment or provide a diagnosis. It is meant as a tool to assist in improved workload prioritization of critical cases. The final diagnosis is provided by a radiologist after reviewing the scan itself. The following modules compose the HealthCXR software for Pleural Effusion: Data input and validation: Following retrieval of a study, the validation feature assessed the input data (i.e. age, modality, view) to ensure compatibility for processing by the algorithm. Pleural Effusion algorithm: Once a study has been validated, the algorithm analyzes the frontal chest x-ray for detection of suspected finding suggestive of pleural effusion. IMA Integration feature: The study analysis and the results of a successful study analysis is provided to IMA, to then be sent to the PACS/workstation for prioritization. Error codes feature: In the case of a study failure during data validation or the analysis by the algorithm, an error is provided to the system.
    Ask a Question

    Page 1 of 1