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510(k) Data Aggregation

    K Number
    K222320
    Device Name
    MedDream
    Manufacturer
    Softneta UAB
    Date Cleared
    2022-12-06

    (126 days)

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

    Softneta UAB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MedDream is a software only Medical Image Management and Processing System intended to display, process, read, report, communicate, distribute, store, and archive medical data which is available as DI COM or HL 7 data, including mammographic images, and bio signals. MedDream also converts case related non-image documents, archives them as DICOM data and serves as a vendor neutral archive. It supports the physician in diagnosis. For primary image diagnosis in Mammography only uncompressed images must be used. Typical users of this system are trained professionals, including but not limited to physicians, radioal technicians, and assistants. Note: Web-based image distribution and mobile device display of mammographic images are not intended for diagnostic purposes. For users in the United States of America: Mobile device display is not intended for diagnostic purposes.
    Device Description
    MedDream is a software only Medical Image Management and Processing System intended to display, process, read, report, communicate, distribute, store, and archive medical data which is available as DI COM or HL 7 data, including mammographic images, and bio signals. MedDream also converts case related non-image documents, archives them as DICOM data and serves as a vendor neutral archive.
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    K Number
    K162011
    Device Name
    MedDream
    Manufacturer
    SOFTNETA UAB
    Date Cleared
    2016-10-14

    (85 days)

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

    SOFTNETA UAB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MedDream is a software medical imaging system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. Software is intended for use as a diagnostic, review, and analysis tool by trained professionals such as radiologists, physicians, clinicians. Contraindications: The MedDream is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only who are qualified to create and diagnose medical image data.
    Device Description
    MedDream is a software medical imaging system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces.
    Ask a Question

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