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510(k) Data Aggregation

    K Number
    K160420
    Device Name
    SpeqT
    Manufacturer
    Date Cleared
    2016-03-21

    (34 days)

    Product Code
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Signostics Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SpeqT is for non-invasive imaging of the human body and is intended for the following applications: Abdominal, Musculoskeletal, Pediatric, and Small Organ. Users must have ultrasound training for abdominal, musculoskeletal, pediatric, and small organ imaging. The SpeqT can also be used to obtain an image of the bladder that is used to automatically determine bladder volume.
    Device Description
    The Signostics Ltd SpecT system is a hand-held, diagnostic ultrasound system with an on-screen display. Its purpose is to acquire ultrasound echo data and display it in B-Mode, on an off-the-shelf display. Automated bladder volume measurements are supported.
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    K Number
    K152250
    Device Name
    SpeqRT
    Manufacturer
    Date Cleared
    2015-09-03

    (24 days)

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

    Signostics Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SpeqRT ultrasound system is for non-invasive imaging of the human body and is intended for the following applications: Fetal, Abdominal, Pediatric, Musculo-skeletal, Cardiac and Peripheral Vessel. Users must have ultrasound training before using the device. See the attached Indications for Use form for specific imaging modes and applications
    Device Description
    The Signostics Ltd SignosRT is a hand-held, diagnostic ultrasound system with an onscreen display. Its purpose is to acquire ultrasound echo data and display it in B-Mode, M-Mode, or Spectral Doppler (PW Doppler) on an LCD display.
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