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510(k) Data Aggregation

    K Number
    K093891
    Device Name
    AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS CORPORATION
    Date Cleared
    2010-11-18

    (335 days)

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

    AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2

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

    This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head, with the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, pancreas, etc.

    The Aquilion ONE has the capability to provide volume sets of the entire organ. These volume sets can then be used to perform specialized studies, using indicated software of the whole organ by a trained and qualified physician.

    The Dual Energy System has been designed to analyze the composition of body materials. The system can load two CT images scanned with two different tube voltages and analyze the composition of the target materials by using the energy dependence of the attenuation coefficients of materials.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a CT system. It does not contain information about acceptance criteria, study details, or performance metrics for a device that would require such an analysis. Therefore, I cannot fulfill your request based on the given input.

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