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510(k) Data Aggregation

    K Number
    K033486
    Device Name
    GE PRECISION MPI
    Manufacturer
    NRT-NORDISK RONTGEN TEKNIK A/S
    Date Cleared
    2003-11-19

    (15 days)

    Product Code
    OWB,LEG
    Regulation Number
    892.1650
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K961374
    Why did this record match?
    Applicant Name (Manufacturer) :

    NRT-NORDISK RONTGEN TEKNIK A/S

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

    The GE Precision MPi is an all-digital multipurpose tilt-C X-ray system, intended for a multitude of diagnostic procedures, including: R&F, radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.

    The GE Precision MPi is a multi-purpose system that can perform general R&F, radiography, fluoroscopy, interventional and angiography procedures/applications.

    Device Description

    The GE Precision MPi tilt-C consists of an X-ray Generator, Right or Left side suspended Angulations Table with X-ray Tube, Collimator and Image Intensifier, Operators console, and Digital Imaging/Archive system.

    AI/ML Overview

    The provided text does not contain any information about acceptance criteria or a study proving device performance in the context of AI/ML or diagnostic accuracy studies.

    This document is a 510(k) premarket notification for a medical device called the "GE Precision MPi Universal tilt-C." It's a traditional medical device (an X-ray system), not an AI/ML powered device.

    The information primarily focuses on:

    • Device Description: An X-ray Generator, Angulations Table with X-ray Tube, Collimator and Image Intensifier, Operators console, and Digital Imaging/Archive system.
    • Intended Use: R&F, radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
    • Technological Differences: States there are no technological differences between the GE Precision MPi and its predicate device (Philips MultiDiagnost 4, K961374).
    • Conformance: Adherence to relevant sections of 21CFR (1020.30, 1020.31, 1020.32) and standards like UL60601-1, IEC60601-1.
    • Conclusion: Substantial equivalence to the predicate device.

    Therefore, I cannot provide the requested table or answer the questions related to AI/ML device performance, sample sizes for test/training sets, ground truth establishment, or expert adjudication, as this information is not present in the given text.

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