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510(k) Data Aggregation

    K Number
    K170978
    Device Name
    Embrace Neonatal MRI System
    Manufacturer
    Aspect Imaging Ltd.
    Date Cleared
    2017-07-19

    (107 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aspect Imaging Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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 displays 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 1Tesla Permanent MRI system producing MR images of 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.
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