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510(k) Data Aggregation

    K Number
    K254190

    Validate with FDA (Live)

    Device Name
    dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T
    Manufacturer
    Philips Medical Systems Nederland B.V.
    Date Cleared
    2026-01-14

    (22 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Special
    Panel
    Radiology
    Age Range
    All
    Reference & Predicate Devices
    K213735,K213766,K123492
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K213735, K213766

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

    The Philips Neurovascular MR Coil is intended to be used in conjunction with a Philips 1.5T or 3T Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.

    Device Description

    A general description of the subject devices, which are part of the Philips Neurovascular MR Coil Family is given below:

    The dS Base 1.5T and dS Base 3.0T are lightweight, 8-channel, phased-array coil that are designed to be used independently or in combination with the dS Head or dS HeadNeck coil. The dS Base coil also can be used for extremities and pediatric examinations or can be combined with the dS Posterior coil which is integrated in the patient support of the compatible Magnetic Resonance (MR) Systems for total spine imaging. The dS Base coil can stay on the table for most examinations without exchanging coils, thereby, improving workflow. These coils are connected to the flex connect socket of the compatible MR System.

    The dS Head 1.5T and dS Head 3.0T are 7-channel receive only coils, which are designed to be used in combination with the dS Base (bottom) coil to create a 15-channel coil with or without the dS Posterior coil which is integrated in the patient support of the compatible MR Systems for total spine imaging. The coil is most frequently used for imaging the head/brain and its vasculature. The coil can also be used for extremities and pediatric examinations. These coils are available in both 1.5T and 3.0T and are connected to the flex connect socket of the compatible MR System.

    The dS HeadNeck 1.5T and dS HeadNeck 3.0T are 8-channel receive only coils, which are designed to be used in combination with the dS Base (bottom) coil to create a 16-channel coil with or without the dS Posterior coil which is integrated in the patient support of the compatible MR Systems for total spine imaging. The coil is used for brain, head, neck, cervical spine, and neurovascular imaging. The coil also can be used for extremities and pediatric examinations. These coils are available in both 1.5T and 3.0T and are connected to the flex connect socket of the compatible MR System

    The dS HeadNeck coil can be used either alone or in combination with the dS Anterior coil and dS Posterior coil. When used in combination with the dS Anterior coil and dS Posterior coil for Whole Body exams this is called a 'Whole Body solution.

    AI/ML Overview

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