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510(k) Data Aggregation

    K Number
    K041947
    Device Name
    I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND
    Date Cleared
    2004-08-16

    (27 days)

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

    INNOVATIVE IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - . Cataracts - Retinal Detachments (a separation of the retina from the middle coat of the eyeball) . - Orbital Lesions . - Tumors 에 - Foreign bodies . - . Inflammation - Vascular Irregularities r The I SYSTEM-ABD™ is a diagnostic ophthalmic ultrasound instrument designed to be used by ophthalmologists for diagnosis of the eye. It is expected that the user is trained in operation of ophinamogiles for the medical interpretation of ultrasonic images. The intended use is the same for the entire I 'SYSTEM-ABD™ product family. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic (A and B mode)
    Device Description
    The difference between the Version 2 system and the existing 13 SYSTEM-ABD™ Diagnostic Ultrasound system is the operating system on which it runs. The new version has a 32-bit operating system, the current version has a DOS based operating system. No changes have been made to any external accessories or probes.
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