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510(k) Data Aggregation

    K Number
    K254277

    Validate with FDA (Live)

    Date Cleared
    2026-03-13

    (73 days)

    Product Code
    Regulation Number
    892.1000
    Age Range
    0 - 0.08
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Embrace Neonatal MRI System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coronal and oblique images that display the internal structure of neonatal head with circumference of up to 38 cm and weight between 1Kg and 4.5 Kg. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

    Device Description

    The Embrace Neonatal MRI System is a 1 Tesla Permanent magnet MRI system producing MR images of the neonatal head. During MRI scan, body parts to be imaged are held within a uniform static magnetic field, and are subject to sequences of RF pulses and gradient magnetic fields. The signal from the precession of the magnetization created by these fields is sampled and processed to produce image data.

    AI/ML Overview

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