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510(k) Data Aggregation

    K Number
    K112002
    Device Name
    CAROTID COIL
    Manufacturer
    SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD
    Date Cleared
    2011-11-18

    (128 days)

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

    SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The carotid coil is a receive-only coil, used for high resolution imaging of the bifurcation of the carotid artery in 1.5T and 3T General Electric, Siemens and Philips Magnetic Resonance Imaging (MRI) systems. Nucleus Excited: Proton 1H Anatomic regions: Carotid. The Carotid Coil is used for obtaining diagnostic images of carotid in magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.
    Device Description
    Carotid Coil is a phased array, receive-only coil. It consists of eight elements optimized for high signal-to-noise ratio. Semi-flexible design makes the coil reliable and comforts the patient. The enclosure, which may contact the patient, is made up of biocompatible material.
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    K Number
    K101949
    Device Name
    PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601
    Manufacturer
    SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD
    Date Cleared
    2010-07-28

    (16 days)

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

    SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pediatric Body-Cardiac Coil is a receive-only coil, used for obtaining diagnostic images of pediatric cardiac and body in Philips Achieva 3.0T magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.
    Device Description
    The Pediatric Body-Cardiac Coil is a phased-array receive-only coil. It consists of eight elements optimized for high signal-to-noise ratio. It includes two parts (upper part and the bottom). The upper part can be easily taken down from the bottom. So the Pediatric Body-Cardiac Coil could be operated expediently. The enclosure is 3.5mm thick PC, which is UL 94V 0 rated and can withstand highest peak RF voltage up to 4200V and drop and impact.
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    K Number
    K101858
    Device Name
    PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701
    Manufacturer
    SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD
    Date Cleared
    2010-07-14

    (12 days)

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

    SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pediatric Head-Spine Coil is a receive-only coil, used for obtaining diagnostic images of pediatric head and spine in magnetic resonance imaging systems. This coil is designed to be used in a Philips Achieva MRI 3.0T system. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.
    Device Description
    The Pediatric Head-Spine Coil is an 8-channel phased array, receive-only coil. It consists of eight elements optimized for high signal-to-noise ratio. Four elements are in the head area and four elements reside in the back portion of the device. It includes two parts (upper part and the bottom). The upper part can be easily taken down from the bottom. So the Pediatric Head-Spine Coil could be operated expediently. The enclosure is 3.5mm thick PC, which is UL 94V_0 rated and can withstand highest peak RF voltage up to 4200V and drop and impact.
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    K Number
    K092962
    Device Name
    CAROTID COIL 5000004901
    Manufacturer
    SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD
    Date Cleared
    2009-10-09

    (14 days)

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

    SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Carotid Coil is a receive-only coil, used for obtaining diagnostic images of carotid in magnetic resonance imaging systems. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.
    Device Description
    The Carotid Coil is an 8-channel phased array, receive-only coil, used for obtaining diagnostic images of carotid in magnetic resonance imaging systems. These images, when interpreted by a trained physician, yields information that may assist in diagnosis.
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    K Number
    K081322
    Device Name
    MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL
    Manufacturer
    SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD
    Date Cleared
    2008-06-18

    (37 days)

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

    SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pediatric Head-Spine Coil is a receive-only coil, used for obtaining diagnostic images of pediatric head and spine in magnetic resonance imaging systems. This coil is designed to be used in a Philips Achieva MRI 1.5T system. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.
    Device Description
    The Model 0100140201 Pediatric Head and Spine Array Coil1.5T 8ch consists is a single unit with eight coils. Four coils are in the head area and four coils reside in the back portion of the device. This forms a 8-channel phased array, receive-only coil, used for obtaining diagnostic images of head and spine of a pediatric body in magnetic resonance imaging systems. Combination of back part and head part forms an 8-channel phased array, receive-only coil, used for obtaining diagnostic images of the head and spine in magnetic resonance imaging systems. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.
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    K Number
    K081340
    Device Name
    PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201
    Manufacturer
    SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD
    Date Cleared
    2008-06-18

    (36 days)

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

    SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pediatric Body-Cardiac Coil is a receive-only coil, used for obtaining diagnostic images of pediatric cardiac and body in Philips Achieva 1.5T magnetic resonance imaging systems. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.
    Device Description
    The Model 0100040201-AP Body Cardiac ArrayCoil1.5T 8ch consists of two parts, bottom part with a cable and a base plate. Bottom part forms an 8-channel phased array, receive-only coil, used for obtaining diagnostic images of body and cardiac of a pediatric body in magnetic resonance imaging systems. Bottom part forms an 8channel phased array, receive-only coil, used for obtaining diagnostic images of the cardiac -body area of a pediatric patient in magnetic resonance imaging systems. These images when interpreted by a trained physician, yield information that may assist in diagnosis.
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    K Number
    K071847
    Device Name
    MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP - KNEE/FOOT/ANKLE COIL
    Manufacturer
    SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD
    Date Cleared
    2007-07-23

    (18 days)

    Product Code
    MOS, 90M
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Knee/Foot/Ankle Coil is a receive-only coil, used for obtaining diagnostic images of knee, foot, ankle and lower leg in conjunction with a PHILIPS 1.5T MRI scanner. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.
    Device Description
    The Knee/Foot/Ankle Coil consists of three parts, bottom part with a cable and a base plate, a knee part and a foot part. The combination of the bottom part and knee part forms a 4-channel phased array, receive-only coil, used for obtaining diagnostic images of knee, foot, ankle and lower leg in magnetic resonance imaging systems. Combination of bottom part and foot part forms a 4-channel phased array, receive-only coil, used for obtaining diagnostic images of foot and ankle. These images, when interpreted by a trained physician, vields information that may assist in diagnosis.
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    K Number
    K071882
    Device Name
    MODEL CG-WHC18-H150-AP - WRIST HAND COIL 1.5T 4 CH,
    Manufacturer
    SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD
    Date Cleared
    2007-07-18

    (9 days)

    Product Code
    MOS, 90M
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The coil is intended to be used in conjunction with a PHILIPS 1.5T MRI scanner as an accessory to produce images of the wrist, hand and elbow.
    Device Description
    The Wrist Hand Coil 1.5T 4ch is a 4-channel phased array, receive-only coil, used for obtaining diagnostic images of wrist, hand and elbow in magnetic resonance imaging systems. These images, when interpreted by a trained physician, yields information that may assist in diagnosis. The elements and associated circuitry of the coil are enclosed in a rigid fire rated housing. The sensitive region of the coil offers an approximate 220x117x83 mm3 field of view. With two opening in the coil, patients can bend their wrists at different angles in scanning process.
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