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510(k) Data Aggregation

    K Number
    K193109
    Device Name
    MRCAT brain
    Manufacturer
    Philips Medical Systems MR Finland
    Date Cleared
    2020-01-24

    (77 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Philips Medical Systems MR Finland

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MRCAT imaging is intended to provide the operator with information of tissue properties for radiation attenuation estimation purposes in photon external beam radiotherapy treatment planning. Indications for use: MRCAT Brain is indicated for radiotherapy treatment planning for primary and metastatic brain tumor patients.
    Device Description
    MRCAT brain is a software application to Ingenia, Ingenia Ambition, and Ingenia Elition MR systems. MRCAT brain is available to the customer as an option to Ingenia MR-RT package, which is a set of accessories for Ingenia systems. Automated generation of MRCAT images takes place at the MR console of Ingenia. The embedded image post-processing runs in the background parallel to image acquisition. MRCAT algorithm enables automatic tissue characterization: Bones are segmented from mDixon in-phase and water images using machine learning based segmentation. Body outline is segmented using in-phase and water images. Tissues are then assigned a continuum of HU values depending on the fat and water intensities of the voxels. The HU assignment provides MRCAT images with CT-like density information.
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    K Number
    K182888
    Device Name
    MRCAT Pelvis
    Manufacturer
    Philips Medical Systems MR Finland
    Date Cleared
    2019-04-30

    (197 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Philips Medical Systems MR Finland

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MRCAT Pelvis is a software add-on for Ingenia 1.5T and 3.0T MR systems. Intended Use: MRCAT imaging is intended to provide the operator with information of tissue properties for radiation estimation purposes in photon external beam radiotherapy treatment planning. Indications for use: MRCAT Pelvis is indicated for radiotherapy treatment planning of soft tissue cancers in the pelvic region.
    Device Description
    MRCAT Pelvis is a software application to Ingenia 1.5T and 3T MR systems. MRCAT Pelvis is available to the customer as an option to Ingenia MR-RT package, which is a set of accessories for Ingenia systems. Automated generation of MRCAT images takes place at the MR console of Ingenia. The embedded image post-processing runs in the background parallel to image acquisition. MRCAT algorithms enable automatic tissue characterization of five tissue types; air, fat, waterrich tissue, spongy bone and compact bone. Subsequent density assignment provides MRCAT images with CT-like density information.
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    K Number
    K151435
    Device Name
    MRCAT
    Manufacturer
    PHILIPS MEDICAL SYSTEMS MR FINLAND
    Date Cleared
    2016-02-25

    (273 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHILIPS MEDICAL SYSTEMS MR FINLAND

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MRCAT is used with Ingenia 1.5T and 3.0T MR systems. Intended Use: MRCAT imaging is intended to provide the operator with information of tissue properties for radiation attenuation estimation purposes in photon external beam radiotherapy treatment planning. Indications for use: MRCAT is indicated for radiotherapy treatment planning for prostate cancer patients.
    Device Description
    MRCAT is a software application to Ingenia 1.5T and 3T MR systems. MRCAT is available to the customer as an option to Ingenia MR-RT package, which is a set of accessories for Ingenia systems. Automated generation of MRCAT images takes place at the MR console of Ingenia. The embedded image post-processing runs in the background parallel to image acquisition. MRCAT algorithms enable automatic tissue characterization of five tissue types; air, fat, water-rich tissue, spongy bone and compact bone. Subsequent bulk-density assignment provides MRCAT images with CT-based density information.
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    K Number
    K080120
    Device Name
    HFO SHOULDER COIL
    Manufacturer
    PHILIPS MEDICAL SYSTEMS MR FINLAND
    Date Cleared
    2008-03-10

    (53 days)

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

    PHILIPS MEDICAL SYSTEMS MR FINLAND

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HFO Shoulder Coil is indicated for use in the following anatomic regions and with the designated nuclei: Anatomic Region: Shoulder and adjacent regions Nuclei Excited: Hydrogen The addition of the HFO Shoulder Coil does not change the existing indications for use of the cleared High Field Open (1.0T) Panorama system, as defined below. The High Field Open (1.0T) Panorama system is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2), and (3) display the soft tissue structure of the head, extremities and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
    Device Description
    The HFO Shoulder Coil consists of a cup-shaped, plastic enclosure containing three coil elements for receiving of RF signals from the shoulder and adjacent region. The enclosure is placed on patient's shoulder for imaging. The enclosure contains tuning and decoupling electronics circuitry and preamplifiers. The coil enclosure has a cable attached to it and the cable connector is plugged into the system connector on the patient table. The cable provides the coil with supply and control voltages and transfers the received RF signals to the system. The cable connector contains coil interface circuitry for the system.
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