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510(k) Data Aggregation

    K Number
    K050297
    Device Name
    SOMATOM EMOTION 16
    Manufacturer
    SIEMENS MEDICAL SOLUTION, INC. USA
    Date Cleared
    2005-03-01

    (22 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K023687
    Predicate For
    K083852,K113287,K133590,K140912
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SOMATOM Emotion 16 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 angels 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 Emotion 16 system is a 16 slice, whole body X-ray computed tomography systems, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The software is syngo-based Somaris/5 software version VB28, which is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

    AI/ML Overview

    This document describes a 510(k) submission for the Siemens SOMATOM Project P10G (SOMATOM Emotion 16) Computed Tomography System. The submission details the device, its intended use, and its substantial equivalence to a predicate device.

    However, the provided text does not contain any information regarding acceptance criteria, device performance, specific studies with sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.

    The document is a standard 510(k) summary for a medical imaging device (CT scanner) from 2005, which predates widespread AI/ML applications in medical devices and the specific types of studies and criteria currently expected for such technologies. The "software" mentioned (syngo-based Somaris/5 software version VB28) refers to the control and reconstruction software for the CT scanner itself, not an AI/ML algorithm for image analysis or diagnosis.

    Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device performance for an AI/ML device based on the provided text. The requested information points to a type of regulatory submission and study design that is not present in this 2005 510(k) summary for a CT hardware system.

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