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510(k) Data Aggregation

    K Number
    K233634
    Device Name
    TeleScan
    Manufacturer
    Date Cleared
    2023-12-12

    (29 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    BB Imaging

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TeleScan® is a software application that is intended for use in receiving, manipulating, displaying, printing, and archiving ultrasound medical images and data can be stored, communicated, and displayed within the system or across computer systems. TeleScan® provides various image processing and measurement tools to facilitate the interpretation of ultrasound DICOM medical images and enable diagnosis. TeleScan® is used by appropriately trained healthcare professionals, including radiologists, sonographers, technologists, and clinicians, in a medical facility. TeleScan® may provide information to be used for diagnostic procedures. TeleScan® allows remote qualified radiologists and clinicians to provide a diagnosis remotely.
    Device Description
    TeleScan® is used by trained medical professionals, including radiologists, sonographers, and clinicians, and may provide information to be used for diagnostic procedures. These individuals are referred to as healthcare workers for the purposes of this submission. Like tele-radiology solutions, TeleScan® allows remotely located qualified radiologists and clinicians to provide a diagnosis. TeleScan® receives DICOM images transmitted ultrasound machines and displays the patient images. This includes cineloops (videos), diagnostics tools for annotation, and a simplified workflow for report creation. TeleScan® is compatible with ultrasound images acquired by appropriately trained healthcare professionals in medical facilities. TeleScan® software provides sonographers with tools to display patient measurements and observations (annotations). The application displays calculated gestational age and growth percentiles based on measurements of anatomical structures. Through a diagnostics function, the estimated fetal weight are calculated. A draft patient report is prepared for further interpretation by medical professionals licensed to sign diagnostic reports, such as physicians, specialists, and nurse practitioners (providers). TeleScan® is offered as software as a service (SaaS) and complies with and data-related laws, including but not limited to HIPAA.
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    K Number
    K220767
    Device Name
    TeleScan
    Manufacturer
    Date Cleared
    2022-04-14

    (29 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    BB Imaging

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TeleScan™ is a software application that is intended for use in receiving, processing, manipulating, displaying, printing, and archiving ultrasound medical images and data. Images and data can be stored, communicated, and displayed within the system or across computer systems. TeleScan™ provides various image processing and measurement tools to facilitate the interpretation of ultrasound DICOM medical images and enable diagnosis. TeleScan™ is used by appropriately trained healthcare professionals. including radiologists, sonographers, technologists, and clinicians, in a medical facility. TeleScan™ may provide information to be used for screening and diagnostic procedures. TeleScar™ allows remote qualified radiologists and clinicians to provide a diagnosis remotely.
    Device Description
    TeleScan™ is used by trained medical professionals, including radiologists, sonographers, technologists, and clinicians, and may provide information to be used for screening and diagnostic procedures. These individuals are referred to as Healthcare Workers (HCWs) for the purposes of this submission. Similar to tele-radiology solutions, TeleScan™ allows remote, qualified radiologists and clinicians to provide a diagnosis remotely. TeleScan™ receives ultrasound DICOM images transmitted from leqally marketed ultrasound machines and displays images. This includes videos (cineloops), diagnostics tools for annotation, and a simplified workflow for report creation. TeleScan™ is compatible with ultrasound images acquired by appropriately trained healthcare professionals in medical facilities. The software provides the Sonographer tools to display patient measurements and observations. The application also calculates gestational age and growth percentiles based on measurements of anatomical structures. Through a diagnostics function, the estimated due date and estimated fetal weight is calculated. The report is prepared for further interpretation by medical professionals licensed to sign diagnostic reports such as physicians, specialists, and nurse practitioners. For the purposes of this submission, these individuals are referred to as "Physicians". TeleScan™ is offered as software as a service (SaaS) and complies with digital health and data related laws, including but not limited to HIPAA.
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