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    K Number
    K973336
    Device Name
    IMEX STETHODOP
    Manufacturer
    IMEX MEDICAL SYSTEMS, INC.
    Date Cleared
    1998-02-05

    (154 days)

    Product Code
    JAF
    Regulation Number
    892.1540
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IMEX STETHODOP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

    Device Description

    IMEX StethoDop™ (Doppler Ultrasound Device)

    AI/ML Overview

    This document is a marketing clearance letter from the FDA for the IMEX StethoDop™ (Doppler Ultrasound Device) with a 5 MHz transducer, dated February 5, 1998. It establishes substantial equivalence to a predicate device and allows the manufacturer to market the device.

    However, the provided text does not contain any information regarding acceptance criteria, device performance, study details (sample sizes, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, or how ground truth was established for training sets.

    The document primarily focuses on regulatory approval, substantial equivalence, manufacturing practices, labeling regulations, and post-clearance reporting requirements related to acoustic output measurements. The "Indications for Use Form" in Appendix F lists various clinical applications and modes of operation for ultrasound systems but does not provide performance metrics or acceptance criteria for the IMEX StethoDop™.

    Therefore, based solely on the provided text, I cannot complete the requested tables and information.

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