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510(k) Data Aggregation

    K Number
    K173138
    Device Name
    Biim Diagnostic Ultrasound System
    Manufacturer
    Date Cleared
    2017-10-27

    (28 days)

    Product Code
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Biim Ultrasound AS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Biim™ Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include: - · Musculo-skeletal (conventional and superficial) - Needle guidance - · Pediatric - · Peripheral Vessel - · Small Organ (breast, thyroid, parathyroid, testicles)
    Device Description
    The Biim Diagnostic Ultrasound System is a portable, general-purpose, software-controlled sonography system based on a digital architecture used to acquire and display high-resolution, real-time ultrasound data through a commercial off-the-shelf iOS or Android device. The Biim Diagnostic Ultrasound System supports wireless transducer connectivity of the ultrasound images to the display device. The Biim Diagnostic Ultrasound System consists of: A commercial off-the-shelf iOS or Android display device Biim Ultrasound software running as an app on the display device The wireless Biim linear array transducer with Biim Ultrasound firmware. Lithium-Ion rechargeable battery Battery charger
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