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510(k) Data Aggregation

    K Number
    K191556
    Device Name
    Red Dot
    Manufacturer
    Behold.AI Technologies Limited
    Date Cleared
    2020-02-28

    (261 days)

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

    Behold.AI Technologies Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The red dot™ software platform 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. red dot™ 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. red dot™ is not intended to direct attention to specific portions of an image or to anomalies other than Pneumothorax. 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
    Behold.ai red dot™ is a radiological computer-assisted triage and notification software system. The software automatically analyzes PA/AP chest x-rays and alerts the PACS/RIS workstation once images with features suggestive of pneumothorax are identified. Through the use of the red dot™ device, a radiologist is able to review studies with features suggestive of pneumothorax earlier than in standard of care workflow. In summary, the red dot™ device provides a passive notification through the PACS/workstation to the radiologists indicating the existence of a case that may potentially benefit from 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. The main components of the red dot™ device are described below. 1. Image input, validation and anonymization After a chest x-ray has been performed, a copy of the study is received and processed by the red dot™ device. Following receipt of a study, the validation feature ensures the image is valid (i.e. has readable pixels) and the anonymization feature removes or anonymizes Personally Identifiable Information (PII) such as Patient Name, Patient Birthdate, and Patient Address. 2. red dot™ Image Analysis Algorithm This component of the device is primarily comprised of the visual recognition algorithm that is responsible for detecting images with potential abnormalities. Once a study has been validated, the algorithm analyzes the frontal chest x-ray for detection of suspected findings suggestive of pneumothorax. 3. PACS Integration Feature The results of a successful study analysis is provided to an integration engine in a standard JSON message containing sufficient information to allow the integration engine to notify the PACS/workstation for prioritization through the worklist interface.
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