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510(k) Data Aggregation

    K Number
    K042328
    Device Name
    SOMATOM SPIRIT
    Date Cleared
    2004-09-14

    (18 days)

    Product Code
    Regulation Number
    892.1750
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    SOMATOM SPIRIT

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

    The SOMATOM Spirit is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. (* spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

    Device Description

    The Siemens SOMATOM Spirit is a whole body X-ray computed tomography stanners, The Siemens SOMATOM 'Spint is a 'Wiole' 600' whole '600' '1. tem' which features a continuously rotaing tube-detector system and functions according to the fan which features a coliminously folling tabe accords of program used for patient beam principle. The system soltware is a control, image reconstruction, and image archive/evaluation.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for the SOMATOM Spirit, a Computed Tomography X-ray System, outlining its safety and effectiveness for substantial equivalence to predicate devices. It focuses on the device description, indications for use, technological characteristics, and general safety and effectiveness concerns related to regulatory standards, rather than performance metrics or a detailed study of its capabilities.

    Therefore, I cannot provide the requested information.

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