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510(k) Data Aggregation

    K Number
    K190362
    Device Name
    HealthPNX
    Manufacturer
    Zebra Medical Vision Ltd.
    Date Cleared
    2019-05-06

    (80 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 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.
    Device Description
    Zebra's HealthPNX is a radiological computer-assisted triage and notification software system. The software automatically analyzes PA/AP chest x-rays and alerts the PACS/workstation once findings suspicious of pneumothorax are identified. The following modules compose the HealthPNX software system: Data input and validation: After a chest x-ray has been performed, a copy of the study is automatically retrieved and processed by the HealthPNX device. Following retrieval of a study, the validation feature assesses the input data (i.e. age, modality, view) to ensure compatibility for processing by the algorithm. HealthPNX algorithm: Once a study has been validated, the algorithm analyzes the frontal chest x-ray for detection of suspected findings suggestive of pneumothorax. IMA Integration feature: The study analysis and the results of a successful study analysis is provided to IMA, that notifies the PACS/workstation through the worklist interface. 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. The radiologist is then able to review the study earlier than in standard of care workflow. In summary, the HealthPNX device is intended to provide a passive notification through the PACS/workstation to the radiologists indicating the existence of a case that may potentially benefit from the prioritization. It doesn't output an image and therefore it does not mark, highlight, or direct users' attention to a specific location on the original chest X ray. The device aim is to aid in prioritization and triage of radiological medical images only.
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