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510(k) Data Aggregation

    K Number
    K260519

    Validate with FDA (Live)

    Date Cleared
    2026-03-20

    (31 days)

    Product Code
    Regulation Number
    892.1000
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Smart Fit TorsoCardiac 1.5T coil is designed to be used in conjunction with a Philips 1.5T MR system to produce diagnostic images of the torso (including chest, abdomen, and pelvis), cardiac, long bones, and neck that can be interpreted by a trained physician.

    Device Description

    The Smart Fit Torsocardiac 1.5T is a 16-channel phased array receive-only coil for high resolution diagnostic imaging of the torso (including chest, abdomen, and pelvis), cardiac, long bones, and neck. The coil foam is composed of PU foil, flexible PCB and EVA to provide sufficient flexibility along Left-Right direction for patient body scan. The layers from outside to patient side are: PU foil (outer surface), EVA30 foam, PCBA of the coil and PU foil (inner surface). The foam looks flat at the top surface. A few parts, two feed-board boxes, cable housing and a small connector placed across the central Head-Feet axis are also at the top surface. Inner surface is naturally flat and is bendable along slots to fit well to the patient body.

    AI/ML Overview

    N/A

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