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510(k) Data Aggregation

    K Number
    K090465
    Device Name
    DIGDOP ULTRASOUND SYSTEM
    Manufacturer
    THE NEWMAN GROUP, LLC
    Date Cleared
    2009-04-08

    (44 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DIGDOP ULTRASOUND SYSTEM

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

    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
    Fetal (CWD - N)
    Peripheral Vascular (CWD - N)

    Device Description

    The system consists of a main body and one probe. The nominal 2 or 3 MHz probes are designed for fetal applications. The nominal 5 or 8MHz probes are designed for peripheral vascular applications.

    AI/ML Overview

    The provided text is related to an FDA 510(k) premarket notification for the "DigiDop Ultrasound System." This document discusses the substantial equivalence of the device to legally marketed predicate devices and outlines its intended uses and transducer types. It is not an AI/ML device and therefore does not include:

    • Acceptance criteria and reported device performance related to AI/ML.
    • Sample sizes, data provenance, number of experts for ground truth, or adjudication methods for test sets.
    • Multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.
    • Ground truth types or sample sizes/ground truth established for training sets.

    The document is purely a regulatory approval for a medical device that uses ultrasound technology to detect fetal heartbeats and for peripheral vascular diagnosis. It does not involve any artificial intelligence or machine learning components.

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