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510(k) Data Aggregation

    K Number
    K140443
    Device Name
    ARIETTA 60/ARIETTAS60/ARIETTAV60
    Manufacturer
    HITACHI ALOKA MEDICAL,LTD. (HITACHI ALOKA MEDICAL
    Date Cleared
    2014-06-16

    (115 days)

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

    HITACHI ALOKA MEDICAL,LTD. (HITACHI ALOKA MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K134016
    Device Name
    ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER
    Manufacturer
    HITACHI ALOKA MEDICAL,LTD. (HITACHI ALOKA MEDICAL
    Date Cleared
    2014-03-28

    (88 days)

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

    HITACHI ALOKA MEDICAL,LTD. (HITACHI ALOKA MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hitachi Aloka Medical. Ltd. AriettaS70 /AriettaV70 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultration of Abdominal. Cardiac. Intra-operative. I ctal. Pediative. Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal. Musculoskeletal. Neonatal Cephalic. Adult Cephalie, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications. The Modes of Operation are B mode. PW mode (Pulsed Wave Doppler). CW mode (Continuous Wave Doppler). Color Doppler. Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography.
    Device Description
    An ultrasound diagnostic system with the following features: - Ultrasound transducer(s) = to generate the transmitted ultrasound energy and detect the reflected echoes - Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) O in various modes of operation - o A computer system - to control the transducer and analyze the signals resulting from the reflected echocs - O A video monitor with optional image recorder - to display the computed image or derived Doppler data
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    K Number
    K122537
    Device Name
    PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0
    Manufacturer
    HITACHI ALOKA MEDICAL,LTD. (HITACHI ALOKA MEDICAL
    Date Cleared
    2013-04-12

    (235 days)

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

    HITACHI ALOKA MEDICAL,LTD. (HITACHI ALOKA MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal, Intra-operative, Intra-operative (Neuro), Laparoscopic, Pediatric, Neonatal Cephalic, Trans-rectal & vaginal, Musculo-skeletal, Gynecological, Cardiac-(Adult, Neonatal, Pediatric), TEE & Peripheral Vascular. The device is not indicated for Ophthalmic applications.
    Device Description
    The Prosound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer type keyboard, specialized controls and a display.
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