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510(k) Data Aggregation

    K Number
    K213070
    Device Name
    MD-320W Ultrasound Biomicroscope
    Manufacturer
    Date Cleared
    2021-11-18

    (56 days)

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

    Meda Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MD-320W Ultrasound Biomicroscope is intended to be used in clinical ophthalmology for ultrasonic diagnosis on the anterior segment of eyes. The device is intended to be used in hospitalmology clinics. The operators should be trained professionals and have basic capabilities for PC operation. It is not allowed to use UBM on patients with eye trauma, inflammation or infection.
    Device Description
    MD-320W Ultrasound Biomicroscope is an ultrasonic imaging system with high-resolution. It consists of AC-DC power adapter, main unit, 50MHz sector scan probe, footswitch, USB cable and two user-selectable APPs: MD3XUBM.AP1-C V1.0 APP (included in MD3XUBM-C V1.0) runs on the windows operating system of the PC and allows the user to control probe scanning, image acquisition and display via the PC user interface. MD3XUBM.AP1-S V1.0 APP (included in MD3XUBM-S V1.0) runs on the operating system of the legally marketed MD-2300S Ultrasonic A/B Scanner for Ophthalmology (K152318) and allows the user to control probe scanning, image acquisition and display via the MD-2300S user interface. Under the excitation of electric pulse, the 50MHz ultrasound transducer emits ultrasonic pulse into eye and receives reflective echo from the surfaces of different tissue, thus forming real-time two-dimensional image of eye tissue.
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    K Number
    K182460
    Device Name
    MD-6000P Bladder Scanner
    Manufacturer
    Date Cleared
    2019-05-06

    (238 days)

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

    Meda Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MD-6000P Bladder Scanner is intended to measure the urine volume in human bladder. The device is intended to be used in medical and nursing care institutions. It should be operated by trained professionals. The device is not intended for use on pregnant women. It cannot be used on wounded skin.
    Device Description
    MD-6000P Bladder Scanner is a hand-held device which utilizes ultrasonic distance measuring principle to calculate urine volume in the bladder. The device takes mechanical sector scan by 2.5MHz ultrasonic waves and recognizes the reflected waves of the front and back walls of bladder to get the area of bladder section; then it makes 12 scans at an interval of 15° and calculates the urine volume in human bladder with volume integral algorithm.
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