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510(k) Data Aggregation

    K Number
    K232762
    Device Name
    dS Breast Coil 7ch 1.5T
    Manufacturer
    Invivo Corporation (Business Trade Name: Philips)
    Date Cleared
    2023-10-03

    (25 days)

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

    Invivo Corporation (Business Trade Name: Philips)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The dS Breast Coil 7ch 1.5T is intended to be used in conjunction with a Philips Prodiva 1.5T CX and a MR 5300 1.5T Magnetic Resonance Scanner to produce diagnostic images of the breast, chest wall, and axillary tissues that can be interpreted by a trained physician.
    Device Description
    The dS Breast Coil 7ch 1.5T is a 7-element phased array receive only coil to be used on a 70cm bore Philips 1.5T MR Systems. The coil is designed to work in unison with the Body Coil of the MRI system, which will transmit the radio frequency (RF) signals, so that the coil may receive the resultant RF signal from the excited nuclei. The subject coil is designed to be used in conjunction with Philips Prodiva 1.5T CS and 1.5T CX MR System (K173507) and with Philips MR 5300 System (K212673) with dStream interfaces. The subject coil is designed for optimum coverage and high-resolution visualization of detailed cartilage structures of the breast anatomy. The coil is used independently and cannot be combined with any other coils. The coil is only available in 1.5T version. The open coil housing design of the dS Breast Coil 7ch 1.5T allows for lateral-medial and cranial-caudal access to the breast for both diagnostic breast imaging and interventional exams.
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    K Number
    K222325
    Device Name
    8ch Wrist Coil
    Manufacturer
    Invivo Corporation (Business Trade Name: Philips)
    Date Cleared
    2022-08-31

    (29 days)

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

    Invivo Corporation (Business Trade Name: Philips)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 8ch Wrist Coil is intended to be used in conjunction with a SIGNA Prime Magnetic Resonance scanner to produce diagnostic images of the wrist anatomy that can be interpreted by a trained physician.
    Device Description
    The 8ch Wrist Coil magnetic resonance (MR) coil is a receive only phased array coil with 8 channels for wrist imaging. This Wrist Coil is designed for use with the SIGNA Prime (K211980). The 8ch Wrist Coil is designed to be used vertically at the patient's side or horizontally overhead. The wrist array comes with two rigid base plates (for flat or curved tabletops) for fixation to reduce patient motion. The coil receives magnetic resonance signals generated in hydrogen nuclei (protons) in the wrist while blocking the high-frequency B1 field applied by the MRI scanner at specified timing. The 8ch Wrist Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation. Images are typically generated as axial, sagittal, coronal oblique slices and include coverage of the wrist anatomy.
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    K Number
    K222257
    Device Name
    1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil
    Manufacturer
    Invivo Corporation (Business Trade Name: Philips)
    Date Cleared
    2022-08-23

    (27 days)

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

    Invivo Corporation (Business Trade Name: Philips)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 1.5T T/R Quad Extremity Coil is intended to be used in conjunction with a SIGNA Prime Magnetic Resonance Scanner to produce diagnostic images of the lower extremities that can be interpreted by a trained physician. The 1.5T 8CH T/R Knee Coil is intended to be used in conjunction with a SIGNA Prime Magnetic Resonance Scanner to produce diagnostic images of the knee that can be interpreted by a trained physician.
    Device Description
    The 1.5T T/R Quad Extremity Coil is quadrature Transmit and Receive coils. At 1.5T the coil can be used in 3 different operational modes: QuadKnee, QuadFoot and QuadAnkle. The coil is designed to image the Knee, Foot and Ankle, but can also be used for other parts of the lower extremities. The base of the coil is attached to a base plate and can be moved to scan either the Left or Right extremity. The coil is moved into position (Left to Right) and locked into place, the patient is then positioned in the base, the top section of the coil is placed over the patient and the latched closed. The fixed position of the coil and helps prevent the patient form moving, reducing artifact. This coil is used independently and can't be combined with any other coils. The 1.5T T/R Quad Extremity Coil is compatible with SIGNA Prime MRI Systems with P-Port Connector. It consists of a birdcage quadrature coil. During transmit phase, the coil is resonated by the RF power source of MR system, to excite hydrogen nuclei (protons) in the anatomy. The quadrature coil detects the magnetic resonance signals generated by hydrogen nuclei (protons) in the knee during the receive phase. The coil is tuned to transmit and receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation. The 1.5T 8CH T/R Knee Coil is an 8 element phase array coil with a T/R quadrature birdcage shell, designed to image the knee. The base of the coil is attached to a base plate and can be moved to scan either the Left or Right Knee. The patient is positioned in the base, the top section of the coil is placed over the patient and the latched closed, which locks the position of the coil and helps prevent the patient form moving, reducing artifact. The transmit shell consist of a twist birdcage quadrature coil, resonated by the RF power source of MR system, to excite hydrogen nuclei (protons) in the anatomy. The coil receivers consist of 8 phased array elements that detect the magnetic resonance signals generated by hydrogen nuclei (protons) in the knee while blocking the high-frequency B1 field applied by the coil transmit shell at specified timings. The coil is tuned to transmit and receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation. This coil is used independently and cannot be combined with any other coils. The 1.5T T/R Quad Extremity Coil and 1.5T 8CH T/R Knee Coil are compatible with SIGNA Prime MRI systems with a P-Port connector.
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    K Number
    K213727
    Device Name
    dS Sentinelle Breast 16ch 3.0T Coil
    Manufacturer
    Invivo Corporation (Business Trade Name: Philips)
    Date Cleared
    2022-08-08

    (255 days)

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

    Invivo Corporation (Business Trade Name: Philips)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The dS Sentinelle Breast 16ch 3T Coil are intended to be used in conjunction with Philips 3.0T Magnetic Resonance Scanners to produce diagnostic images of the breast anatomy that can be interpreted by a trained physician. When used with a disposable biopsy grid, the device permits access to breast anatomy for biopsy and localization procedures.
    Device Description
    The dS Sentinelle Breast 16 Ch 3.0T MR Coils is a receive only coil to be used on a 70cm bore Philips Ingenia 3.0T MR System. The coil arrays are designed to correspond with the scanner strength. The dS Sentinelle Breast 16Ch 3T coil is a phased array design consisting of patient support with three different coil configurations (2, 10 or 16 channels): 1. 16Ch for diagnostic imaging: performed in 16Ch configuration that consists of two dS Sentinelle Lateral 4Ch coils and the dS Sentinelle Medial 8Ch coil. 2. 10Ch for bilateral interventional procedures requiring lateral access: performed in 10Ch configuration that consists of the dS Sentinelle Medical 8Ch coil and two dS Sentinelle Lateral 1Ch coils (right and left). 3. 2Ch for unilateral interventional procedures allowing both lateral and medial access: performed in 2Ch configuration that consists of two dS Sentinelle Lateral 1Ch coils (right and left). The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the Breast while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings. The coil arrays include 4Ch right and left lateral coils, a medial coil and 1Ch right and left lateral biopsy coils. Images are typically generated as axial, sagittal, coronal and oblique slices and include full coverage of the breast anatomy. The dS Sentinelle Breast 16Ch 3T Coil is tuned to receive RF frequency corresponding to the proton precession in a 3.0 tesla magnetic field (respectively), which is governed by the Larmor equation. The Variable Coil Geometry design of the dS Sentinelle Breast 16Ch 3T Coil allows each imaging element to be independently positioned and configured for each patient. Patients can then be positioned quickly and effectively as the imaging elements can be positioned as close to the breast as possible optimizing the signal-to-noise ratio for each individual patient. For clinical imaging, coil housings are placed next to the tissue to help minimize motion artifacts due to patient motion during scanning. The subject dS Sentinelle Breast Coil system also includes a tabletop compression system which facilitates immobilization of the breast for imaging and interventional procedures and serves to hold the individual imaging coils in proximity to the breast(s). The intent of this is to reduce motion artifacts and ensure the imaging elements are positioned as close to the breast(s) as possible to optimize signal-to-noise ratio and image quality.
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    K Number
    K213735
    Device Name
    dS Sentinelle Breast 16ch 1.5T Coil
    Manufacturer
    Invivo Corporation (Business Trade Name: Philips)
    Date Cleared
    2022-08-08

    (252 days)

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

    Invivo Corporation (Business Trade Name: Philips)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The dS Sentinelle Breast 16ch 1.5T Coil is intended to be used in conjunction with Philips 1.5T Magnetic Resonance Scanners to produce diagnostic images of the breast anatomy that can be interpreted by a trained physician. When used with a disposable biopsy grid, the device permits access to breast anatomy for biopsy and localization procedures.
    Device Description
    The dS Sentinelle Breast 16ch 1.5T Coil is a receive only coil to be used on a 70cm bore Philips Ingenia 1.5T MR System. The coil arrays are designed in a magnetic strength (1.5T) to correspond with the scanner strength. The dS Sentinelle Breast 16ch 1.5T Coil is a phased array design consisting of patient support with three different coil configurations (2, 10 or 16 channels): 1. 16Ch for diagnostic imaging: performed in 16ch configuration that consists of two dS Sentinelle Lateral 4Ch coils and the dS Sentinelle Medial 8Ch coil. 2. 10Ch for bilateral interventional procedures requiring lateral access: performed in 10Ch configuration that consists of the dS Sentinelle Medical 8ch coil and two dS Sentinelle Lateral 1ch coils (right and left). 3. 2Ch for unilateral interventional procedures allowing both lateral and medial access: performed in 2Ch configuration that consists of two dS Sentinelle Lateral 1Ch coils (right and left). The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the Breast while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings. The coil arrays include 4Ch right and left lateral coils, a medial coil and 1Ch right and left lateral biopsy coils. Images are typically generated as axial, sagittal, coronal and oblique slices and include full coverage of the breast anatomy. The dS Sentinelle Breast 16ch 1.5T Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation. The Variable Coil Geometry design of the dS Sentinelle Breast 16ch 1.5T Coil allows each imaging element to be independently positioned and configured for each patient. Patients can then be positioned quickly and effectively as the imaging elements can be positioned as close to the breast as possible optimizing the signal-to-noise ratio for each individual patient. For clinical imaging, coil housings are placed next to the tissue to help minimize motion artifacts due to patient motion during scanning. The subject dS Sentinelle Breast 16ch 1.5T Coil system also includes a tabletop compression system which facilitates immobilization of the breast for imaging and interventional procedures and serves to hold the individual imaging coils in proximity to the breast(s). The intent of this is to reduce motion artifacts and ensure the imaging elements are positioned as close to the breast(s) as possible to optimize signal-to-noise ratio and image quality.
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    K Number
    K213351
    Device Name
    ds Head 32ch 3.0T
    Manufacturer
    Invivo Corporation (Business Trade Name: Philips)
    Date Cleared
    2021-10-29

    (21 days)

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

    Invivo Corporation (Business Trade Name: Philips)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The dS Head 32ch 3.0T MR Coil is intended to be used in conjunction with a Philips 3.0T Magnetic Resonance Scanner to produce diagnostic images of the head on adult and pediatric patients that can be interpreted by a trained physician.
    Device Description
    The subject dS Head 32ch 3.0T Coil is a receive-only, phased-array radiofrequency (RF) coil designed for high-resolution head examinations on adult and pediatric patients. The coil is intended for use with Philips magnetic resonance (MR) scanners with a 3.0 tesla magnetic field strength.
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