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510(k) Data Aggregation

    K Number
    K152318
    Device Name
    MD-2300S Ultrasonic A/B Scanner for Ophthalmology
    Manufacturer
    Date Cleared
    2015-11-17

    (92 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-2300S Ultrasonic A/B Scanner for Ophthalmology is intended for ophthalmological ultrasonic diagnosis and AL biometric measurement. The 10MHz B-Probe applies to normal ophthalmological ultrasonic diagnosis; and the 20MHz B-Probe is suitable for observing the details of intraocular and retina structure. The device should be operated by trained medical staff. Patients with eyelid trauma and severe eye infection are prohibited from using B-Scan; and patients and cornea trauma are prohibited from using A-Biometric scan. The A-biometric scan should be used cautiously on patients without independent behavior abilities or who are highly sensitive to contacting measurements, whose ineffective cooperation may result in inaccurate measurements,
    Device Description
    MD-2300S Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging instrument specialized in ophthalmological diagnosis. It consists of a main unit, a power adaptor, a 10MHz B-Scan probe, a 20MHz B-Probe, a 10MHz A-Probe, a footswitch, a keyboard and a mouse. MD-2300S includes two most popular operation modes for ophthalmological clinical diagnosis: B-mode ultrasonic section imaging and A-mode axial biometric parameter measurement. The 10MHz B-Probe applies to normal ophthalmological ultrasonic diagnosis; and the 20MHz B-Probe is suitable for observing the details of intraocular and retina structure. The part of B-mode uses 10MHz and 20MHz mechanical sector-scan probes for scanning. It acquires echo signal through ultrasonic pulse transmitting and receiving circuits; and converts it into digital information to save in FIFO; the data information of each echo line is transmitted to the embedded board through USB port. The application software running on Windows XPE platform realizes real time display, saving and case report generation for images of eye tissue. The part of A-mode uses 10MHz A-biometric probe for A-mode scanning. It acquires echo signal through ultrasonic pulse transmitting and receiving circuits; and converts it into digital information to save in FIFO; the data information of each echo line is transmitted to the embedded board through USB port. Based on the interface reflection of ultrasound wave in three different tissues of anterior chamber, lens and vitreous body, the application software running on Windows XPE platform measures the transmitting time of ultrasound wave in different tissues and then calculates distances of each segment according to the acoustic velocity of different tissues to get the axial length and generates case report of A-biometry automatically, thus provides parameters for intraocular lens implantation operation.
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