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510(k) Data Aggregation

    K Number
    K233734
    Device Name
    Interson USB Ultrasound System
    Manufacturer
    Interson Corporation
    Date Cleared
    2023-12-22

    (30 days)

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

    Interson Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Interson USB Ultrasound System is intended for diagnostic ultrasound imaging in B, color Doppler, M mode or Combined (B+ Color) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal/Obstetric Abdominal Pediatric Small Organ Trans-Rectal Trans-Vaginal Musculo-skeletal (conventional) Musculo-skeletal (superficial) Urology Gynecology Pelvic Floor Neuro-muscular Cardiac Peripheral Vessel The system is intended for use by trained healthcare professionals having a general knowledge of the use of ultrasound imaging devices and imaging protocols in environments where healthcare is provided by healthcare professionals.
    Device Description
    The Interson USB Ultrasound Imaging System (Proposed) is a self-contained portable, solid-state, multiple-mode and multiple-application ultrasound imaging system. The system comprises a series of handheld probes containing an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface, and software-based controls offering a full complement of conventional operating modes, parameter controls, and recording functions. The system operates in B, color Doppler, M mode and combined B + color Doppler modes. The selection of transducers offered with the system permits a wide range of clinical applications including Abdominal, Fetal, Pediatric, Musculoskeletal, Cardiac, Small organ. Neuro-muscular, Urology, OB/Gyn and Peripheral vessel.
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    K Number
    K163443
    Device Name
    Interson USB Ultrasound System
    Manufacturer
    Interson Corporation
    Date Cleared
    2017-04-13

    (126 days)

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

    Interson Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Interson USB Ultrasound System is intended for diagnostic ultrasound imaging in B, color Doppler, or Combined (B + Color) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: - Fetal/Obstetric Abdominal Pediatric Small Organ Musculo-skeletal (conventional) Musculo-skeletal (superficial) Urology Gynecology Pelvic Floor Neuro-muscular Peripheral Vessel The system is intended for use by healthcare professionals.
    Device Description
    The Interson USB Ultrasound Imaging System is a self-contained portable, solid-state, multiple-mode and multiple-application ultrasound imaging system. The system comprises a series of handheld probes containing an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface, and software-based controls offering a full complement of conventional operating modes, parameter controls, and recording functions. The selection of transducers offered with the system permit a wide range of clinical applications including Fetal/Obstetric, Abdominal, Pediatric, Small Organ, Musculo-skeletal, Urology, Gynecology, Pelvic Floor, Neuromuscular, and Peripheral Vessel. The initial operational settings for each transducer are preprogrammed in the system. User-customized parameter settings for each transducer may be set by the operator and stored for recall as needed via the system control panel. Customization includes transmit power, images controls selection, and Time Gain Compensation (TGC). Controls are also provided to select display format and to utilize the Cine function. The Interson USB Ultrasound transducers operate in B-Mode, color Doppler, and combined mode (B + color Doppler), providing high resolution and high penetration performance. The product family uses curved and flat linear array transducers and includes a General Purpose (GP) probe and a Small Parts (SP) probe. The SeeMore software application used in the Interson USB Ultrasound System supports static image acquisition and a cine function capable of storing up to 32 to 1024 sequential images. Management of patient history is enabled by the image or cine-storage function. The SeeMore control software runs on standard Microsoft Windows platforms.
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