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510(k) Data Aggregation

    K Number
    K070884
    Device Name
    POD B-SCAN
    Date Cleared
    2007-04-11

    (12 days)

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

    STARFISH PRODUCT ENGINEERING INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The POD B-Scan is intended to be used for visualization by ultrasound of the eye and orbit by A-scan and B-scan. The POD B-Scan System is a multi-purpose computer-based ultrasound diagnostic system for ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye.
    Device Description
    The POD B-Scan is intended to be used for visualization by ultrasound of the eve and orbit by A-scan and B-scan. The system is PC-based, and can be used with 35 MHz or 50MHz transducers. Because of the higher frequency of the transducers, it is expected that its greatest field of application will be in visualizing the anterior segment, because the focus area is about 11 mm from the transducer plane. The system can visualize other parts of the eye. Summary of the reaconventional ophthalmic A and B-scan system using a motor-driven transducer and angle sensor for scanning. The A-scan is derived from the B-scan. There is a choice of transducer frequency of 35 MHz or 50 MHz. It uses a motor-driven 10 MHz transducer with an attached angle encoder. The system is PC-based, and the display is on the computer screen.
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