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510(k) Data Aggregation

    K Number
    K231085
    Device Name
    1.5T HD T/R Knee Array (10-F34127)
    Date Cleared
    2023-08-18

    (123 days)

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

    Shenzhen RF Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Knee Coil manufactured by Shenzhen RF Tech Co.,Ltd. is transmit/receive coil and is designed for use as general purpose coil. The Knee Coil is designed to be use with GEHC 1.5T MRI systems to produce diagnostic images of the knee, palm, sole, ankle, elbow, wrist that can be interpreted by a trained physician.
    Device Description
    The 1.5T HD T/R Knee Array is transmit/receive phased array coil to produce diagnostic images of images of the knee, palm, sole, ankle, elbow, wrist. The 1.5T HD T/R Knee Array 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.
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    K Number
    K223203
    Device Name
    1.5T 24E Posterior Array
    Date Cleared
    2023-03-02

    (139 days)

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

    Shenzhen RF Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 1.5T 24E Posterior Array by Shenzhen RF Tech Co., Ltd is receive-only coil and designed to be used with GE 1.5T MRI systems to produce diagnostic images of spine, when used with other coils, it also includes abdomen, torso, pelvis, prostate, cardiac, hips, and long bone imaging that can be interpreted by a trained physician.
    Device Description
    The 1.5T 24E Posterior Array is receive only phased array coil to produce diagnostic images of Spine, when used with other coils, it also includes abdomen, torso, pelvis, prostate, cardiac, hips, and long bone. The 1.5T 24E Posterior Array 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.
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    K Number
    K223225
    Device Name
    8ch T/R Knee Coil
    Date Cleared
    2023-02-14

    (119 days)

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

    Shenzhen RF Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 8ch T/R Knee Coil manufactured by Shenzhen RF Tech Co.,Ltd is transmit/receive coil and is designed for use as general purpose coil. The 8ch T/R Knee Coil is designed to be use with GE 1.5T MRI systems to produce diagnostic images of the knee, palm, sole, ankle, elbow, wrist that can be interpreted by a trained physician.
    Device Description
    The 8ch T/R Knee Coil is transmit/receive phased array coil to produce diagnostic images of images of the knee, palm, sole, ankle, elbow, wrist. The 8ch T/R Knee 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.
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    K Number
    K223239
    Device Name
    8ch Wrist Coil
    Date Cleared
    2022-12-08

    (49 days)

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

    Shenzhen RF Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 8ch Wrist Coil by Shenzhen RF Tech Co.,Ltd is receive-only coil and is designed for use as general purpose coil. The 8ch Wrist Coil is designed to be use with GE 1.5T MRI systems to produce diagnostic images of the wrists and fingers that can be interpreted by a trained physician.
    Device Description
    The 8ch Wrist Coil is receive only phased array coil to produce diagnostic images of the wrists and fingers in adult population. 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. The 8ch Wrist Coil is based on phased array technique to produce the images from 8 different channels with intergraded preamplifiers. The 8ch Wrist Coil is tuned to the proton frequency of 63.86MHz.
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    K Number
    K200836
    Device Name
    8ch Flex Suite
    Date Cleared
    2020-07-22

    (113 days)

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

    Shenzhen RF Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 1.5T 8ch Flex Suite manufactured by Shenzhen RF Tech Co.,Ltd is receive-only coil and is designed for use as general purpose coil. The 1.5T 8ch Flex Suite is designed to be use with GE 1.5T MRI systems to produce diagnostic images of upper and lower extremities, head, spine and cardiac that can be interpreted by a trained physician.
    Device Description
    The 1.5T 8ch Flex Suite is receive-only phased array coil for imaging the upper and lower extremities, head and spine in adult population. The 1.5T 8ch Flex Suite consists of three flexible and lightweight coil of different size that can be wrapped or orientated flat, in order to accommodate various anatomic shapes and sizes. The 1.5T 8ch Flex Suite 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.
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    K Number
    K172222
    Device Name
    8ch Flex Suite
    Date Cleared
    2017-12-08

    (137 days)

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

    Shenzhen RF Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 1.5T 8ch Flex Suite manufactured by Shenzhen RF Tech Co., Ltd is receive-only coil and is designed for use as general purpose coil. The 1.5T 8ch Flex Suite is designed to be use with GE 1.5T MRI systems to produce diagnostic images of upper and lower extremities, head and spine that can be interpreted by a trained physician.
    Device Description
    The 1.5T 8ch Flex Suite is receive-only phased array coil for imaging the upper and lower extremities, head and spine in adult population. The 1.5T 8ch Flex Suite consists of three flexible and lightweight coil of different size that can be wrapped or orientated flat, in order to accommodate various anatomic shapes and sizes. The 1.5T 8ch Flex Suite 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 1.5T 8ch Flex Suite is flexible and can be wrapped around the anatomy of interest, which is similar to its predicate device. The 1.5T 8ch Flex Suite is general purpose receive only coil with 8 elements and intergraded preamplifiers. The 1.5T 8ch Flex Suite is based on phased array technique for combining the images from 8 different channels. The 1.5T 8ch Flex Suite is tuned to the proton frequency of 63.86MHz.
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    K Number
    K160932
    Device Name
    8ch Foot Ankle Coil
    Date Cleared
    2016-08-01

    (119 days)

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

    Shenzhen RF Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    8ch Foot Ankle Coil manufactured by RFT is a receive-only RF surface coil designed for use with GE 3.0T MRI systems. 8ch Foot Ankle Coil is indicated to use for foot and ankle imaging. The nucleus excited is hydrogen.
    Device Description
    The 8ch Foot Ankle Coil is a surface coil used for Magnetic Resonance Imaging. It's tuned to image Proton nuclei in a receive-only configuration. It is comprised of 8 individual Phased Array coil elements which receive the signal from patient's foot or ankle. Preamplifiers are integrated in the coil. The geometry is optimized for use with parallel imaging techniques. The 8ch Foot Ankle Coil receives foot or ankle signal through 8-element phased array under 3T static magnetic field and presents the foot or ankle images based on the above mentioned theory. The 8ch Foot Ankle Coil comprises the coil and the base plate. The coil conforms to patients' anatomy, accommodating various foot contours while minimizing patient discomfort. The base plate separated from the coil part is used to place the patients' anatomy on the table. The associated accessories include: - 1 cable - 1 baseplate, - 1 ankle pad, - 1 foot pad, - 1 ramp pad, - 1 knee pad support, - 1 strap.
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    K Number
    K160935
    Device Name
    8ch Foot Ankle Coil
    Date Cleared
    2016-07-28

    (115 days)

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

    Shenzhen RF Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    8ch Foot Ankle Coil manufactured by RFT is a receive-only RF surface coil designed for use with GE 1.5T MRI systems. 8ch Foot Ankle Coil is indicated to use for foot and ankle imaging. The nucleus excited is hydrogen.
    Device Description
    The 8ch Foot Ankle Coil is a surface coil used for Magnetic Resonance Imaging. It's tuned to image Proton nuclei in a receive-only configuration. It is comprised of 8 individual Phased Array coil elements which receive the signal from patient's foot or ankle. Preamplifiers are integrated in the coil. The geometry is optimized for use with parallel imaging techniques. The 8ch Foot Ankle Coil comprises the coil and the base plate. The coil conforms to patients' anatomy, accommodating various foot contours while minimizing patient discomfort. The base plated from the coil part is used to place the patients' anatomy on the table. 8ch Foot Ankle Coil is 8-channel phased array RF receive only coils with integrated preamplifiers. The coil designs consist of RF chokes with switching diodes to provide decoupling which isolates the coil elements from RF fields during RF transmission.
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