LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K101816
    Device Name
    STN PROBE
    Manufacturer
    SUMMIT DOPPLER SYSTEMS, INC.
    Date Cleared
    2010-08-19

    (50 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K024197
    Why did this record match?
    Device Name :

    STN PROBE

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

    This product will be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

    Device Description

    The LifeDop is a hand-held, battery powered, audio Doppler device used for blood flow detection in veins and arteries: The product includes sterilizable detachable ultrasound transducer probe and user replaceable batteries. The user interface includes an on/off button, volume control, single 2-1/4" speaker and battery. The product is housed in custom injection molded housings. Patient contact materials are ABS and Ploycarbonate injection molded plastic.

    AI/ML Overview

    The provided text is a 510(k) summary for the Summit Doppler Systems, Inc. STN Probe. It describes the device, its intended use, and claims substantial equivalence to a previously cleared predicate device (LifeDop Doppler Ultrasound System -- w/ 8.0 MHz CW PV Probe K024197).

    Crucially, the document states "None provided" for Clinical Testing. This means no acceptance criteria or study data demonstrating the device meets such criteria are present in this submission. The basis for clearance is solely substantial equivalence to a predicate device, assuming similar features, materials, and intended use.

    Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about a study proving the device meets acceptance criteria, as this information is explicitly stated as not provided in the submitted material.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1