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510(k) Data Aggregation

    K Number
    K110920
    Device Name
    UF-760AG
    Date Cleared
    2011-04-08

    (7 days)

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

    FUKUDA DENSHI CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The system is intended for use by a qualified physician for diagnostic ultrasound imaging or fluid flow analysis of the human body in Fetal/Obstetric, Gynecological, Abdominal (renal, Gyn/Pelvic), Small Organ (thyroid, breast, testes, etc.), Adult Cephalic, Trans-cranial, Musculoskeletal (conventional & superficial), Cardiac-Adult/Pediatric/Fetal. Transesophageal (Cardiac), Peripheral vascular. The UF-760AG ultrasound instrument is intended to perform the following diagnostic ultrasound investigations: Imaging (B-mode, 3D/4D, harmonic imaging), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler (CW Doppler), Power Doppler Tissue Imaging, Color Flow Mapping (CFM) and Color Time Motion (CM)
    Device Description
    The UF-760AG ultrasound instrument is intended to perform the following diagnostic ultrasound investigations: Imaging (B-mode, 3D/4D), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler (CW Doppler), Color Flow Mapping (CFM) and Color Time Motion (CM). The submission also includes the transducers necessary for these procedures. The system is a portable unit approximately 14.5" wide, 14.4" deep and 3.9" high equipped with a keyboard control panel, a 15" TFT screen, assorted transducers and image storage or hard-copy devices.
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    K Number
    K081919
    Device Name
    UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM
    Date Cleared
    2008-09-09

    (64 days)

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

    FUKUDA DENSHI CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small organs (Thyroid, Breast, Testicle), Adult Cephalic, Cardiac, Transesophageal, Transvaginal, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial. Mode of Operation: A, B, M, PW D, CW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD).
    Device Description
    The UF-870AG is an ultrasound instrument intended to perform the following diagnostic ultrasound investigations: Imaging (B-mode), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler (CW Doppler), Color Flow Mapping (CFM) and Color Time motion (CM mode). The submission also includes the transducers necessary for these procedures. The system is a mobile console approximately 19" wide, 31" deep and 53-57" high equipped with a keyboard control panal, a large TFT screen, assorted transducers and image storage or hard-copy devices.
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