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510(k) Data Aggregation

    K Number
    K020151
    Device Name
    UD-1000 ULTRASONIC A/B SCANNER
    Manufacturer
    Date Cleared
    2002-04-10

    (84 days)

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

    TOMEY CORP. USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UD-1000 A/B Scanner is indicated for: - Ultrasound imaging of the eye and orbit - Producing axial measurements of the eye - Imaging the intraocular anatomy and pathology of the eye - Imaging the anterior segment of the eye - Imaging the anterior angle for Glaucoma Management - Imaging of other structures of the anterior chamber
    Device Description
    This instrument is designed as an ophthalmic diagnostic instrument that performs both Amode and B-mode ultrasound. In B-mode, the instrument acquires an ultrasonic crosssectional image of echoes from ocular structures. The brightness of the various dots in the two-dimensional image depends on the intensity of the echo sources. In A-mode, the instrument provides a one-dimensional display of returning echoes. Positive waves indicate the location of ocular structures; the distances between spikes can be measured. The B-scan probe transmits focused ultrasonic waves into the eyeball. The transducer oscillates back and forth, resulting in a two-dimensional cross-sectional image view of the ocular structures. The image represents a "slice" through the portion of eye that is being examined. The ultrasonic beam focus range is controlled by six annular oscillators that are arranged concentrically. Multiple images can be saved and played back at the most appropriate resolution. The B-scan probe is used to indirectly measure axial length based on a linear sampling of the image of the eye. Although this measurement is less accurate than axial length measurement by A-scan biometry, it provides a useful approximation in patients unable to maintain a steady primary gaze or in eyes with dense cataract, detached retina or posterior staphyloma. The A-scan probe emits a non-focused ultrasound beam that results in a one-dimensional representation of echoes returned from ocular structures through which the beam passes. Ocular abnormalitites may be identified and evaluated by assessing the location and amplitude of the spikes produced by various ocular tissues. The instrument control panel is a touch panel with membrane switch, rotary encoder and foot switch.
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