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510(k) Data Aggregation

    K Number
    K160559
    Device Name
    NOBLUS™ Ultrasound Diagnostic System
    Manufacturer
    HITACHI MEDICAL CORPORATION
    Date Cleared
    2016-10-18

    (232 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    HITACHI MEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Noblus™ Ultrasound Diagnostic System is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative (Spec.), Intra-operative (Neuro.), Transesophageal (Cardiac) - Adult/Pediatric, Wound (Cavernous/Non-Cavernous), Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology, and Laparoscopic clinical applications. The modes of Operation of the Hitachi Noblus™ Ultrasound Diagnostic System are B mode, M mode (Pulse Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, and Real Time Tissue Elastography.
    Device Description
    An ultrasound diagnostic system with the following features: - Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the reflected echoes O - Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) O in various modes of operation - A computer system to control the transducer and analyze the signals resulting from the reflected echoes O - A video monitor with optional image recorder to display the computed image or derived Doppler data O
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