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510(k) Data Aggregation

    K Number
    K201995
    Device Name
    CUBEScan BioCon-1100
    Manufacturer
    Mcube Technology Co., Ltd.
    Date Cleared
    2020-08-19

    (30 days)

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

    Mcube Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CUBEScan BioCon-1100 is a B-mode pulsed-echo ultrasound device. The BioCon-1100 projects ultrasonic energy through the lower abdomen of a patient to obtain images of the bladder to calculate the urine volume non-invasively. The BioCon-1100 is intended to be used by a qualified medical professional in hospitals and other healthcare facilities to non-invasively measure the urine volume in the bladder. Contraindications for the BioCon-1100 are fetal use on pregnant patients.
    Device Description
    The CUBEScan BioCon-1100 (Bladder volume measurement system) is a safe, easy to use, noninvasive system for measuring bladder volume (residual volume). The CUBEScan BioCon-1100 is a B-mode ultrasound device, which consists of a probe that sends and receives ultrasonic waves, and a console that processes ultrasonic signals and converts them into the desired data. The 3Dmechanical sector transducer take the bladder in 12 sections and calculate the volume of the bladder based on the images which appear on the LCD screen. In addition, the pre-scan function allows users to easily locate the location of the bladder before scanning, making measurement easier. Measurement results can be transferred to a computer, and data can be managed using CubePro-1100.
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    K Number
    K200749
    Device Name
    CUBEScan BioCon-900S
    Manufacturer
    Mcube Technology Co., Ltd.
    Date Cleared
    2020-05-19

    (57 days)

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

    Mcube Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CUBEScan BioCon-900S is a B-mode pulsed-echo ultrasound device. The BioCon-900S projects ultrasonic energy through the lower abdomen of a patient to obtain images of the bladder to calculate the urine volume non-invasively. The BioCon-900S is intended to be used by a qualified medical professional in hospitals and other healthcare facilities to non-invasively measure the urine volume in the bladder. Contraindications for the BioCon-900S are fetal use and use on pregnant patients.
    Device Description
    CUBEScan BioCon-900S is a safe and easy, non-invasive system to measure the bladder volume. The device consists of a probe and various components. The probe is a B-mode instrument, which is hand-held, wireless and battery-operated. A 3D-mechanical sector transducer provides crosssectional images of the bladder from up to 12 scan planes which users can check through the screen and bladder volume is calculated based upon those images. In addition, the Pre-scan function allows users to easily locate the bladder before scanning, making measurement easier. CUBEScan BioCon-900S consists of a probe and CUBEscan Charger or a probe and CUBEScan Docking Station, with an optional mobile cart and a barcode module.
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    K Number
    K200548
    Device Name
    CUBEScan BioCon-1100
    Manufacturer
    Mcube Technology Co., Ltd.
    Date Cleared
    2020-03-27

    (24 days)

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

    Mcube Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CUBEScan BioCon-1100 is a B-mode pulsed-echo ultrasound device. The BioCon-1100 projects ultrasonic energy through the lower abdomen of a patient to obtain images of the bladder to calculate the urine volume non-invasively. The BioCon-1100 is intended to be used by a qualified medical professional in hospitals and other healthcare facilities to non-invasively measure the urine volume in the bladder. Contraindications for the BioCon-1100 are fetal use and use on pregnant patients.
    Device Description
    The CUBEScan™ BioCon-1100 (Bladder volume measurement system) is a safe, easy to use, noninvasive system for measuring bladder volume (residual volume). The CUBEScan™ BioCon-1100 is a B-mode ultrasound device, which consists of a probe that sends and receives ultrasonic waves, and a console that processes ultrasonic signals and converts them into the desired data. The 3Dmechanical sector transducer take the bladder in 12 sections and calculate the volume of the bladder based on the images which appear on the LCD screen. In addition, the pre-scan function allows users to easily locate the location of the bladder before scanning, making measurement easier. Measurement results can be transferred to a computer, and data can be managed using CubePro-1100.
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    K Number
    K171591
    Device Name
    CUBEScan™ BioCon-900 (Bladder Volume Measurement System)
    Manufacturer
    Mcube Technology Co., Ltd.
    Date Cleared
    2017-06-22

    (22 days)

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

    Mcube Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BioCon-900 is a B-mode pulsed-echo ultrasound device. The BioCon-900 projects ultrasonic energy through the lower of a patient to obtain images of the bladder to calculate the urine volume non-invasively. BioCon-900 is intended to be used by a qualified medical professional to non-invasively measure the urine in the bladder. Contraindications for the BioCon-900 are fetal use and use on pregnant patients.
    Device Description
    CUBEScan™ BioCon-900 (bladder volume measurement system) is a safe and easy, non-invasive system to measure the bladder volume. CUBEScan™ BioCon-900 is a B-mode instrument, hand-held, wireless and battery-operated. A 3D-mechnical sector transducer provides cross-sectional images of the bladder from up to 12 scan planes and bladder volume is calculated based upon those images and displays 12 scan planes on a screen. Furthermore, a live image of the bladder during Pre-Scan makes it easier to detect the bladder before scanning. Measurements are transmitted to a personal computer running CubePro software via a wireless connection. CubePro allows the user to print measurements, archive data and so on.
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    K Number
    K111021
    Device Name
    CUBESCAN / BIOCON-700
    Manufacturer
    MCUBE TECHNOLOGY CO., LTD.
    Date Cleared
    2011-04-27

    (15 days)

    Product Code
    ITX, IYO
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    MCUBE TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioCon-700 is a B-mode pulsed-echo ultrasound device. The BioCon-700 is intended as a portable battery-operated device. The BioCon-700 projects ultrasonic energy through the abdomen of the patient obtaining images of the bladder in order to calculate the urine volume non-invasively. BioCon-700 is intended to be used by a qualified medical professional to non-invasively measure the urine volume in the bladder. Contraindications for the BioCon-700 are fetal use and use on pregnant patients.
    Device Description
    The BioCon-700 is a portable ultrasound system for measuring the urine volume in a patient. BioCon-700 transmits ultrasound signals to the abdomen of a patient and receives the echoed signals. Using the echoed signals the system detects the bladder outlines and calculates the volume in bladder outlines. BioCon-700 has a Pre-scan function, which shows the ultrasound images for a horizontal plane consisted of the echoed signals. The Pre-scan function helps a user locate the bladder easily and get more accurate results. A user can print the results using a build-in thermal printer after measurements right away. Also using the optional CubePro software, a user can review the scan results.
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    K Number
    K091518
    Device Name
    CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM
    Manufacturer
    MCUBE TECHNOLOGY CO., LTD.
    Date Cleared
    2009-06-18

    (27 days)

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

    MCUBE TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioCon-500 is a B-mode pulsed-echo ultrasound device. The BioCon-500 is intended to project ultrasound energy through the abdomen of the patient to obtain images of the bladder and to calculate the bladder volume non-invasively using these images. Contraindications for the BioCon-500 are fetal use and use on pregnant patients.
    Device Description
    The BioCon-500™ is a portable ultrasound system for measuring the urine volume in a patient. BioCon-500™ transmits ultrasound signals to the abdomen of a patient and receives the echoed signals. Using the echoed signals the system detects the bladder outlines and calculates the volume in bladder outlines. BioCon-500™ has a Pre-Scan function, which shows the ultrasound images for a horizontal plane consisted of the echoed signals. The Pre-Scan function helps a user locate the bladder easily and get more accurate results. A user can print the results using a built-in thermal printer after measurements right away. Also using the optional CubeScanPC software you can upload the saved data in a device's flash ROM to a computer for reviewing the scan results.
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