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510(k) Data Aggregation

    K Number
    K130262
    Device Name
    MAGNETOM ESSENZA WITH SYNGO MR D14
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Date Cleared
    2013-03-01

    (28 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Type
    Special
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K083166,K100141,K060873,K071925,K121434
    Why did this record match?
    Reference Devices :

    K083166, K100141, K060873

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

    The MAGNETOM ESSENZA with syngo MR D14 is indicated for use as magnetic resonance diagnostic devices (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

    The MAGNETOM ESSENZA may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR-safe biopsy needles.

    Device Description

    The MAGNETOM ESSENZA is being upgraded with software syngo MR D14. The MAGNETOM ESSENZA is a 1.5T, whole body scanner designed for economical optimized reasons. Siemens intends to modify the cover, gradient coil, Physiological Measurement Unit (PMU), Measurement and Reconstruction System (MaRS), update the software and add two new coils for the existing MAGNETOM ESSENZA Magnetic Resonance System.

    AI/ML Overview

    The provided document is a 510(k) summary for the Siemens MAGNETOM ESSENZA 1.5T System with syngo MR D14 software. This document primarily focuses on demonstrating substantial equivalence to a predicate device and adherence to regulatory standards for a Magnetic Resonance Diagnostic Device (MRDD).

    Crucially, this document does NOT contain information about acceptance criteria or a study that proves the device meets specific performance criteria related to the diagnostic accuracy (e.g., sensitivity, specificity) of an AI-powered diagnostic algorithm.

    The 510(k) submission for the MAGNETOM ESSENZA with syngo MR D14 is for an imaging hardware system (a 1.5T MRI scanner) with updated software, coils, and mechanical components. It is not for an AI/algorithm-driven diagnostic aid. Therefore, the types of studies and acceptance criteria typically associated with AI-powered diagnostic devices (e.g., MRMC studies, sensitivity/specificity targets, expert adjudication for ground truth) are not applicable to this specific submission and are consequently not present in the provided text.

    The document indicates that the device's substantial equivalence is based on:

    • Its intended use being the same as the predicate (K071925).
    • The fact that it is an upgrade to an existing, cleared MRI system.
    • Conformity to applicable FDA-recognized and international IEC, ISO, and NEMA standards for performance and safety.
    • Risk management in compliance with ISO 14971:2007.

    Therefore, I cannot populate the requested table or answer the specific questions related to AI acceptance criteria and performance studies based on the provided text.

    To reiterate, the provided document describes a magnetic resonance diagnostic device (MRI scanner), not an AI-driven diagnostic algorithm. The "performance" discussed in this context relates to the safety and functionality of the imaging system itself, not the diagnostic accuracy of an AI interpreting images.

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