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510(k) Data Aggregation

    K Number
    K052338

    Validate with FDA (Live)

    Device Name
    SOLAR GI
    Manufacturer
    MEDICAL MEASUREMENT SYSTEMS,B.V.
    Date Cleared
    2005-12-15

    (111 days)

    Product Code
    FFX
    Regulation Number
    876.1725
    Type
    Special
    Panel
    Gastroenterology/Urology
    Age Range
    All
    Reference & Predicate Devices
    K032336
    Predicate For
    K091070,K240007
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Solar GI system is intended to record, store, view and analyse pressure, EMG, swallow and respiration and various auxiliary input device data on-line anywhere in the gastrointestinal tract (pharynx, esophagus, stomach, duodenum, sphincter of oddi, small bowel, colon and anorectal area including rectum and pelvic floor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. Designated catheters and accessories are required for measurement in each specific area.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the "Solar GI including CIM-AUX Module". It indicates that the device has been found substantially equivalent to legally marketed predicate devices. However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot answer your request based on the provided input. The document is primarily a regulatory approval letter and not a performance study report.

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