Search Filters

Search Results

Found 6 results

510(k) Data Aggregation

    K Number
    K142368
    Device Name
    NOBLUS DIAGNOSTIC ULTRASOUND SCANNER
    Manufacturer
    HITACHI ALOKA MEDICAL, LTD.
    Date Cleared
    2015-01-14

    (142 days)

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

    HITACHI ALOKA MEDICAL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hitachi 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.), Trans-esophageal (Cardiac, Non-Cardiac) - Adult/Pediatric, Wound (Cavernous), Fetal, Pediatric, Small Organ, Peripheral vessel, Biospy, Trans-rectal, Trans-vaginal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Adult Cephalic, Endoscopy, Intraluminal, Gynecology, Urology, and Laparoscopic clinical applications. The modes of operation of the Hitachi Noblus™ Ultrasound Diagnostic System are B mode, M mode, PW mode (Pulse Wave Doppler), CW mode (Continuous Wave Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D 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 - Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) in various modes of operation - A computer system to control the transducer and analyze the signals resulting from the reflected echoes - A standard Lithium ion computer battery to allow for system portability - A video monitor with optional image recorder to display the computed image or derived Doppler data
    Ask a Question
    K Number
    K140854
    Device Name
    INTRA-OPERATIVE ULTRASOUND TRANSDUCER
    Manufacturer
    HITACHI ALOKA MEDICAL, LTD.
    Date Cleared
    2014-06-11

    (69 days)

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

    HITACHI ALOKA MEDICAL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hitachi Aloka Medical. Ltd. UST-5310 / UST-5311 transducers for use with the PROSOUND ALPHA6 Diagnostic Citrasound scanner are intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrassund evaluation during Intra-operative and Intra-operative (neurosurgery) procedures. The device is not indicated for Ophthalmic applications.
    Device Description
    Linear Array transducer
    Ask a Question
    K Number
    K140639
    Device Name
    PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
    Manufacturer
    HITACHI ALOKA MEDICAL, LTD.
    Date Cleared
    2014-04-16

    (35 days)

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

    HITACHI ALOKA MEDICAL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal; Abdominal; Intra-operative (neurosurgery); Laparoscopic; Pediatric; Small Organ; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac Adult - TEE; Cardiac Neonatal; Cardiac Pediatric - TEE; Peripheral Vascular; and Gynecological applications. The device is not indicated for Ophthalmic applications.
    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) in various modes of operation - A computer system to control the transducer and analyze the signals resulting from the reflected echoes - A video monitor with optional image recorder to display the computed image or derived Doppler data
    Ask a Question
    K Number
    K130308
    Device Name
    NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM
    Manufacturer
    HITACHI ALOKA MEDICAL, LTD.
    Date Cleared
    2013-04-05

    (57 days)

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

    HITACHI ALOKA MEDICAL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hitachi Noblus™ Ultrasound Diagnostic System is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, 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, PW mode (Pulse Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D 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 - Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) in various modes of operation - A computer system to control the transducer and analyze the signals resulting from the reflected echoes - A standard Lithium ion computer battery to allow for system portability - A video monitor with optional image recorder to display the computed image or derived Doppler data
    Ask a Question
    K Number
    K123828
    Device Name
    PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
    Manufacturer
    HITACHI ALOKA MEDICAL, LTD.
    Date Cleared
    2013-01-18

    (37 days)

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

    HITACHI ALOKA MEDICAL, LTD.

    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 (Neurosurgery); Pediatric; Small Organ; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac, Adult -TEE; Cardiac - Neonatal; Cardiac - Pediatric; Cardiac Pediatric, TEE; Peripheral Vascular; and Gynecological applications. The device is not indicated for Ophthalmic applications.
    Device Description
    The Prosound F75, formerly named Aloka Prosound F75, 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. The changes made to the Prosound F75 are the expanded indications: Adult/ Pediatric Cardiac- TEE, Neonatal/Pediatric, Cardiac, Intraoperative Neurosurgery, and Trans-esoph (non-cardiac).
    Ask a Question
    K Number
    K122341
    Device Name
    PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37
    Manufacturer
    HITACHI ALOKA MEDICAL, LTD.
    Date Cleared
    2012-09-26

    (55 days)

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

    HITACHI ALOKA MEDICAL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1