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510(k) Data Aggregation

    K Number
    K122009
    Device Name
    AIDA VI.8 DIAGNOSTIC ULTRASOUND GM-72P00A, L13-5V1 TRANSDUCER
    Date Cleared
    2012-10-03

    (86 days)

    Product Code
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    PANASONIC HEALTHCARE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AIDA V1.8 Diagnostic Ultrasound System GM-72P00A is intended for Peripheral Vessel application. The system provides ultrasound imaging information such as the visualization of anatomical structures, characteristics and dynamic processes within the human body using ultrasound to aid diagnosis. The AIDA V1.8 Diagnostic Ultrasound System GM-72P00A also provides an automated intima-media thickness measurement of peripheral vessels such as the common carotid in the BIMT-mode of operation for heart rate range of 20-150 beats per minute. This system is contraindicated for fetal use.
    Device Description
    The AIDA V1.8 Diagnostic Ultrasound System GM-72P00A is a portable ultrasound system optimized to perform a non-invasive examination of the peripheral vessels. The system provides ultrasound imaging information such as the visualization of anatomical structures, characteristics and dynamic processes within the human body using ultrasound to aid diagnosis. This system also provides an automated measurement of the intima-media thickness (IMT) of peripheral arteries such as the common carotids and allows the user to search for arterial plaques using realtime Brightness, Color Doppler and Pulse Doppler imaging modes. The touchscreen keyboard allows the user to input various parameters relating to traditional cardiovascular risk factors. A built in calculator provides risk scores commonly used in a variety of geographical locations (Framingham Risk Score, PROCAM Health Check Score, Reynolds Risk Score, Risk score based on the SCORE Project). This information is supplemented with an IMT measurement of the artery to generate a comprehensive report of cardiovascular risk assessment.
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    K Number
    K113612
    Device Name
    AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A
    Date Cleared
    2012-02-10

    (66 days)

    Product Code
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    PANASONIC HEALTHCARE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AIDA V1.5 Diagnostic Ultrasound System GM-72P00A is intended for Peripheral Vessel applications. The system provides an automated intima-media thickness measurement of peripheral vessels such as the common carotid in the BIMT-mode of operation for heart rate range of 20-150 beats per minute. The AIDA V1.5 Diagnostic Ultrasound System GM-72P00A is contraindicated for fetal use.
    Device Description
    The AIDA V1.5 Diagnostic Ultrasound System GM-72P00A is a portable ultrasound system optimized to perform a non-invasive examination of the peripheral vessels. It provides an automated measurement of the intima-media thickness (IMT) of peripheral arteries such as the common carotids and allows the user to search for arterial plaques using real-time Brightness and Color Doppler imaging modes. The touchscreen keyboard allows the user to input various parameters relating to traditional cardiovascular risk factors. A built in calculator provides risk scores commonly used in a variety of geographical locations (Framingham Risk Score, PROCAM Health Check Score, Reynolds Risk Score, Risk score based on the SCORE Project). This information is supplemented with an IMT measurement of the artery to generate a comprehensive report of cardiovascular risk assessment.
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    K Number
    K103148
    Device Name
    AIDA DIAGNOSTIC ULTRASOUND SYSTEM
    Date Cleared
    2011-03-11

    (137 days)

    Product Code
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    PANASONIC HEALTHCARE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AIDA diagnostic ultrasound system is intended for Peripheral Vessel applications. The system provides an automated intima-media thickness measurement of peripheral vessels such as the common carotid in the BIMT mode of operation for heart rate range of 20-150 beats per minute. The AIDA ultrasound system is contraindicated for fetal use.
    Device Description
    The AIDA diagnostic ultrasound system is a portable ultrasound system optimized to perform a non-invasive examination of the peripheral vessels. It provides an automated measurement of the intima-media thickness (IMT) of peripheral arteries such as the common carotids and allows the user to search for arterial plaques using real-time B-mode imaging. The touchscreen keyboard allows the user to input various parameters relating to traditional cardiovascular risk factors. A built in calculator provides risk scores commonly used in a variety of geographical locations (Framingham Risk Score, PROCAM Health Check Score, Reynolds Risk Score, Risk score based on the SCORE Project). This information is supplemented with an IMT measurement of the artery to generate a comprehensive report of cardiovascular risk assessment.
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