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510(k) Data Aggregation

    K Number
    K103659
    Device Name
    CS 9300, CS 9300C
    Manufacturer
    TROPHY
    Date Cleared
    2011-08-18

    (246 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CS 9300, CS 9300C

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

    The CS 9300 and CS 9300C are systems intended to produce two-dimensional and three-dimensional digital x-ray images of the dento-maxillo-facial, and ENT (Ear, Nose and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.

    In addition, the CS 9300C is intended to produce cephalometric images. This includes imaging the hand and wrist to obtain the carpus image for growth and maturity assessment.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the CS 9300 and CS 9300C computed tomography x-ray systems. It outlines the FDA's determination of substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria, reported device performance data, details of a study (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), or information on ground truth establishment for a training set.

    Therefore, I cannot fulfill your request for that detailed information based solely on the provided text. The document confirms the device's clearance for marketing based on substantial equivalence, but it does not present the technical study details you are asking for.

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