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510(k) Data Aggregation

    K Number
    K152126
    Device Name
    UST-5550-R; UST-5536-R; L43K
    Manufacturer
    HITACHI ALOKA MEDICAL AMERICA, INC.
    Date Cleared
    2016-08-17

    (383 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    HITACHI ALOKA MEDICAL AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UST-5550-R and UST-5536-R transducer is intended for use with the PROSOUND ALPHA 7 Diagnostic Ultrasound Systems by trained personnel (doctor, sonography, etc.) for the diagnostic ultrasound evaluation during robotic* and non-robotic** intra-operative and laparoscopic procedures. The L43K transducer is intended for use with the ARIETTA60, ARIETTA 70 and NOBLUS Diagnostic Ultrasound Systems by trained personnel (doctor, sonography, etc.) for diagnostic ultrasound evaluation during robotic* and non-robotic** intra-operative and laparoscopic procedures. This device is not indicated for Ophthalmic applications. *For robotic use, these devices can only be used with the da Vinci™ Surgical System and da Vinci™ 8 mm ProGrasp Forceps. **For non-robotic use, these devices can only be used with the Covidien SILST™ Clinch
    Device Description
    Linear Array transducer
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    K Number
    K153421
    Device Name
    HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS
    Manufacturer
    HITACHI ALOKA MEDICAL AMERICA, INC.
    Date Cleared
    2016-01-21

    (57 days)

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

    HITACHI ALOKA MEDICAL AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HI VISION Ascendus is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Trans-esophageal (Cardiac) - Adult/Pediatric, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications. The modes of operation of the HI VISION Ascendus are B mode, M mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Dual Doppler mode, CFI mode (Color Flow Image), Amplitude Dopper (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, Real-time Virtual Sonography, Real-time Tissue Elastography and Shear Wave Measurement.
    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 - O Ultrasound transducer accessories (standard and optional) - to maximize functional usage of transducer(s) in various modes of operation - O 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
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    K Number
    K142618
    Device Name
    Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System
    Manufacturer
    Hitachi Aloka Medical America, Inc.
    Date Cleared
    2014-10-16

    (30 days)

    Product Code
    ITX, DEV
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hitachi Aloka Medical America, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hitachi Aloka Medical, Ltd UST-5310 or UST-5311 or UST-5311-TIP transducers are intended for use with the PROSOUND ALPHA 6, PROSOUND ALPHA 7 and ARIETTA70 Diagnostic Ultrasound systems by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation during intraoperative and Intra-operative (neurosurgery) procedures. This device is not indicated for Ophthalmic applications.
    Device Description
    Linear Array transducer
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