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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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    K Number
    K160185
    Device Name
    Wrist 3
    Manufacturer
    ASPECT IMAGING LTD
    Date Cleared
    2016-03-01

    (34 days)

    Product Code
    LNH, MOS
    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 Wrist 3 MRI System is intended for use as a magnetic resonance imaging device for producing axial, sagittal, coronal, and oblique images of the internal structure of the Wrist and Hand. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
    Device Description
    The Wrist 3 MRI System is a 1Tesla Permanent MRI system producing MR images of the wrists and hands. 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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    K Number
    K130692
    Device Name
    M2 WRIST 2 MRI SYSTEM
    Manufacturer
    ASPECT IMAGING LTD
    Date Cleared
    2014-01-14

    (307 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 M2 Wrist 2 MRI System is indicated for use as a magnetic resonance imaging device for producing transverse, sagittal and coronal images of the internal structure of the wrist (in patients with an arm length > 320mm). When interpreted by a trained physician, the resultant MR images provide information that can be useful in determining a diagnosis.
    Device Description
    The M2 Wrist 2 MRI System is a 1 Tesla, compact, high-performance solution, based on a permanent magnet. Due to its remarkable structure, the external magnetic field is very low, thus offering unique safety advantage. The system has very low Eddy currents and exhibits very low gradient-related acoustic noise. The magnet is self-shielded and thus no RF shielded room is required. The type of installation is fixed. The M2 Wrist 2 MRI System's main components are: Magnet Sub-system, Wrist Coil, Electronics Cabinet, Aspect Imaging Proprietary Software, Computer, Isolation Transformer.
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    K Number
    K120701
    Device Name
    M2 WRIST MRI SYSTEM
    Manufacturer
    ASPECT IMAGING LTD
    Date Cleared
    2013-02-07

    (337 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 M2 Wrist MRI System is indicated for use as a magnetic resonance imaging device for producing transverse, sagittal and coronal images of the internal structure of the wrist (in patients with an arm length > 320mm). When interpreted by a trained physician, the resultant MR images provide information that can be useful in determining a diagnosis.
    Device Description
    The Wrist MRI is a 1 Tesla high-performance solution, using NdFeB magnetic material, providing routinely 250 micron or better resolution. The system is Eddy - currents free with gradients which have high strength and a fast slew rate. The Wrist MRI is designed to ensure maximum safety of operation. Its negligible external magnetic-field eliminates the need for a specially shielded room and other limiting operational procedures. The Wrist MRI system's main components are: Magnet Sub-system, Wrist Coil, Electronics Cabinet, Aspect Imaging Proprietary Software, Computer, Isolation Transformer.
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