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510(k) Data Aggregation

    K Number
    K243428
    Device Name
    e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector
    Manufacturer
    DxTx Medical, Inc.
    Date Cleared
    2025-07-17

    (254 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Product Code :

    MOS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K244054
    Device Name
    16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)
    Manufacturer
    Quality Electrodynamics
    Date Cleared
    2025-02-28

    (59 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Product Code :

    MOS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 16CH Flex SPEEDER Medium is intended for use with Canon 1.5T MR systems to produce diagnostic images of general human anatomy that can be interpreted by a trained physician. The 16ch Flex SPEEDER Large coil is intended for use with Canon 1.5T MR systems to produce diagnostic images of general human anatomy that can be interpreted by a trained physician.
    Device Description
    The 16ch Flex Speeder Medium and 16ch Flex Speeder Large coils are a receive-only, 16-channel phased array coil designed for magnetic resonance imaging (MRI) using the Canon 1.5T MR systems. The 16ch Flex Speeder Medium and 16ch Flex Speeder Large coils are intended to be used for general anatomies.
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    K Number
    K243675
    Device Name
    InkSpace Imaging Small Body Array
    Manufacturer
    InkSpace Imaging, Inc.
    Date Cleared
    2024-12-20

    (23 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Product Code :

    MOS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InkSpace Imaging Small Body Array is a receive-only coil, used for obtaining diagnostic images of general human anatomy in adult and pediatric patients such as cardiac, spine, shoulder, elbow, knee, foot, and prostate in Siemens 1.5T magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.
    Device Description
    The InkSpace Imaging Small Body Array is a phased array, receive-only coil intended to work with Siemens 1.5T MRI scanners for body MR imaging examinations. The coil is comprised of 24 total channels, with two individual flexible pads, each containing 12 individual elements. The elements are flexible to conform to patients' anatomies.
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    K Number
    K243316
    Device Name
    XENOVIEW 3.0T Chest Coil
    Manufacturer
    Polarean, Inc.
    Date Cleared
    2024-11-19

    (28 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Product Code :

    MOS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Polarean XENOVIEW 3.0T Chest Coil is to be used in conjunction with compatible 3.0T Magnetic Resonance Imaging (MRI) scanners and approved xenon Xe 129 hyperpolarized for oral inhalation of lung ventilation in adults and pediatric patients aged 12 years and older.
    Device Description
    The Polarean XENOVIEW 3.0T Chest Coil (hereafter Chest Coil) is a flexible, single channel, transmit-receive (T/R) RF coil tuned to 123xe frequency on a 3.0T MRI magnetic field in order to image 129Xe nuclei while the patient is positioned inside a compatible multi-nuclear-capable MRI scanner. The Chest Coil is intended to be worn by a patient who inhales hyperpolarized 100%e gas (XENOVIEW) to obtain an MR image of the regional distribution of hyperpolarized 199xe in the lungs. The coil is constructed of a durable, flexible circuit board material within which the antenna elements and all electronic components are contained. These components are electrically isolated from the rest of the coil packaging by being enclosed within suitable non-conductive. water-rated, and flame-rated materials. A layer of padding is located on either side of the coil circuitry to provide patient comfort and protection against potential heating generated by circuitry components. The RF coil is a "fixed matching and tuning device" (i.e. not tunable by the operator), thereby eliminating the need to tune and match it for every patient.
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    K Number
    K242879
    Device Name
    dS Knee Coil 8ch 1.5T
    Manufacturer
    Philips Medical Systems Nederland B.V.
    Date Cleared
    2024-10-18

    (25 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Product Code :

    MOS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The dS Knee Coil 8ch 1.5T is to be used in conjunction with Philips 1.5T Magnetic Resonance Scanner to produce diagnostic images of Knee that can be interpreted by a trained physician.
    Device Description
    The dS Knee Coil 8ch 1.5T is an 8 channel phased array, receive only coil with a rigid volume and designed to be used in conjunction with 1.5T Magnetic Resonance Scanner for high resolution imaging of the left or right knee. The split design and single handle allows easy setup. The coil can be slightly rotated relative to its base plate to ease coil setup and enhance patient comfort. The coil conforms snugly to the anatomy for excellent signal-to-noise ratio. This coil is used independently and cannot be combined with any other coil and is available for Philips 1.5T Prodiva and MR 5300 MR Systems.
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    K Number
    K243033
    Device Name
    dS Wrist coil 8ch 1.5T
    Manufacturer
    Philips Medical Systems Nederland B.V.
    Date Cleared
    2024-10-18

    (21 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Product Code :

    MOS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The dS Wrist Coil 8ch 1.5T is intended to be used in conjunction with Philips 1.5T Magnetic Resonance Scanner to produce diagnostic images of the wrist that can be interpreted by a trained physician.
    Device Description
    The dS Wrist Coil 8ch 1.5T is an 8-channel phased-array coil with rigid volume coils of 8 elements that closely encircle the wrist for high SNR. This coil for Prodiva and MR5300 is a one-piece, hinged design for easy patient set-up. To reduce patient motion artifacts, the dS Wrist coil includes one rigid base plate to fixate the coil & allowing for overhead and at the side examinations. This coil is only available in 1.5T. This coil is used independently and cannot be combined with any other coils
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    K Number
    K242096
    Device Name
    dS FootAnkle Coil 8ch 1.5T
    Manufacturer
    Philips Medical Systems Nederland B.V.
    Date Cleared
    2024-08-12

    (25 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Product Code :

    MOS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The dS FootAnkle Coil 8ch 1.5T is intended to be used in conjunction with Philips Magnetic Resonance Scanner to produce diagnostic images of the foot and ankle that can be interpreted by a trained physician.
    Device Description
    The dS FootAnkle Coil 8ch 1.5T is a phased-array, receive-only coil with rigid volume consisting of 8 elements. This coil is a ski-boot-shaped coil designed for optimum coverage and highresolution visualization of the ankle and entire foot down to the toes. The coil design and element lavout allow for either large field of view (FOV) imaging of the whole foot or small FOV high resolution imaging of ankle joints. The coil is easy to set up and can be used with the patient's foot positioned vertically. These coils are used independently and cannot be combined with any other coils and are available for 1.5T Prodiva/ MR 5300 MR Systems.
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    K Number
    K241069
    Device Name
    iLoop Interventional Coil 0.55T
    Manufacturer
    NORAS MRI products GmbH
    Date Cleared
    2024-06-07

    (49 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Product Code :

    MOS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the iLoop Interventional Coil 0.55T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human body. Used in a magnetic resonance tomograph, the iLoop Interventional Coil 0.55T is intended to produce transversal, sagittal, coronal and oblique images of the internal structures of the body. This device may be used for interventional procedures.
    Device Description
    The iLoop Interventional Coil 0.55T is a 1-channel receiver coil that can be used for MR imaging before, during and after MR-guided interventions with a Siemens MRI System with field strength 0.55T. The iLoop Interventional Coil 0.55T can also be used as a standard diagnostic coil for diagnostic examination of the human body. The iLoop Interventional Coil 0.55T is a coil that can be used on many different regions of the body. Used in conjunction with a sterile, self-adhesive OP-drape, the coil enables the workflow for MR-guided interventions
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    K Number
    K233652
    Device Name
    Contour Hand/Wrist (Q7000232)
    Manufacturer
    Quality Electrodynamics
    Date Cleared
    2024-02-16

    (94 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Product Code :

    MOS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Contour Hand/Wrist is intended for use with Siemens 0.55T MR systems to produce diagnostic images of hand and wrist anatomy that can be interpreted by a trained physician.
    Device Description
    The Contour Hand/Wrist is a receive-only, 12-channel phased array coil designed for magnetic resonance imaging (MRI) using the Siemens 0.55T MR systems. The Contour Hand/Wrist is intended to be used for imaging hand and wrist anatomy.
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    K Number
    K233656
    Device Name
    Contour Shoulder
    Manufacturer
    Quality Electrodynamics
    Date Cleared
    2024-02-15

    (93 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Product Code :

    MOS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Contour Shoulder is intended for use with Siemens 0.55T MR systems to produce diagnostic images of shoulder anatomy that can be interpreted by a trained physician.
    Device Description
    The Contour Shoulder is a receive-only, 12-channel phased array coil designed for magnetic resonance imaging (MRJ) using the Siemens 0.55T MR systems. The Contour Shoulder is intended to be used for imaging Shoulder anatomy. The Contour Shoulder is a reusable, non-invasive device with regard to duration of contact with the body. The central coil elements are enclosed in a rigid plastic housing which is fire-rated, has impact and has been tested for biocompatibility. The flexible wing coll elements are encapsulated in polycarbonate and aramid felt which is fire-rated, has impact and tensile strength, then covered with a polyurethane coated nylon fabric which has been evaluated for biocompatibility.
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