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510(k) Data Aggregation

    K Number
    K960421
    Device Name
    SINUSCAN 102/SINUSPRINT
    Manufacturer
    FERGUSON MEDICAL
    Date Cleared
    1997-04-16

    (443 days)

    Product Code
    LWI
    Regulation Number
    892.1560
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K874081
    Why did this record match?
    Device Name :

    SINUSCAN 102/SINUSPRINT

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

    The Oriola Sinuscan 102/Sinusprint device is intended for use in the ultrasound detection of frontal and maxillary sinusitis.

    Device Description

    The Oriola Sinuscan 102/ Sinusprint is a pulsed ultrasound scanner. The Oriola Sinuscan 102/Sinusprint device functions by ultrasonic sending pulses of energy and receiving echoes from acoustic interfaces in the manner of an echo sounder. The reflected echoes are converted to an electric signal and concise on the LCD display and/or printed by the printer.

    AI/ML Overview

    This document is a 510(k) summary for the Oriola Sinuscan 102/Sinusprint device, a pulsed ultrasound scanner intended for the detection of frontal and maxillary sinusitis. It does not contain information about acceptance criteria, device performance, studies, ground truth establishment, or sample sizes.

    Therefore, I cannot provide the requested information based on the provided text. The document focuses on the device's classification, proprietary name, substantial equivalence, description, intended use, and technological characteristics, as required for a 510(k) submission.

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