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510(k) Data Aggregation

    K Number
    K121243
    Device Name
    ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER
    Manufacturer
    MEDA CO. LTD.
    Date Cleared
    2013-05-03

    (373 days)

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

    MEDA CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MD-1000A/P is used for ophthalmology to measure axial length (AL), anterior chamber depth (ACD), lens thickness (LT), and corneal thickness (CT). The MD-1000A is used for ophthalmology to measure axial length (AL), anterior chamber depth (ACD) and lens thickness (LT). The MD-1000P is used for ophthalmology to measure corneal thickness (CT). The device should be operated by trained doctors. It should be used cautiously to patients without independent behavior abilities. Cornea trauma or inflammation patients are prohibited to use the device.
    Device Description
    The MD-1000 Series of Ultrasonic Biometer/Pachymeter for Ophthalmology consists of three models of products: the MD-1000A/P Ultrasonic Biometer for Ophthalmology, the MD-1000A Ultrasonic Biometer for Ophthalmology and the MD -1000P Ultrasonic Pachymeter. The MD-1000A/P Ultrasonic Biometer for Ophthalmology is an ultrasonic measuring instrument based on pulse reflection. The MD-1000A/P contains two function units: A Mode Eye Axis Biometric Parameter Measuring Unit (A Biometer) and Corneal Thickness Measuring Unit (Pachymeter). The A Biometer consists of a 10MHz A-Probe (probe model: Prb1000A/10-C) and an axis biometric parameter measuring unit. The axis is usually divided into three segments: anterior chamber, lens and vitreous body. Since the tissue within the eye varies in different areas, the acoustic velocity through these areas is also different. The summation of these three segments (ACD + LENS + VITR) provides the axial length (AL). Based on the interface reflections of the three different tissues, the ultrasonic A-biometry measures the transmitting time of ultrasound through each tissue and calculates the length of each segment to finally get the axial length. The Pachymeter consists of a 20MHz P-Probe (probe model: Prb1000P) and the measuring unit. It is on the basis of the measurement of the time interval between the anterior and posterior interface reflection waves of cornea to get the corneal thickness (CT). The MD-1000 Series has a built-in Thermal Printer, used to print out patient information, A-Scan measuring waveform, IOL calculating parameter and result as corneal thickness measuring result and corneal thickness distribution map. The built-in memory of the MD-1000 Series can store up to180 patients' records. After examination, it can be connected with a computer to upload the stored measuring data and information, thus realizing mass storage.
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    K Number
    K113304
    Device Name
    BLADDER SCANNER
    Manufacturer
    MEDA CO. LTD.
    Date Cleared
    2012-03-23

    (136 days)

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

    MEDA CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MD-6000 Bladder Scanner is a portable battery-operated ultrasonic equipment of pulse reflection. It is intended to measure the volume of bladder filled with urine. The MD-6000 is intended to be used only by qualified medical professionals. Contraindications for the MD-6000 are fetal use and use on pregnant patients.
    Device Description
    MD-6000 Bladder Scanner is a portable battery-operated ultrasonic equipment of pulse reflection. It utilizes ultrasonic distance measuring principle to calculate the bladder volume. It makes mechanical sector scan by 2.5MHz ultrasonic wave and recognizes the reflected wave of the front and back wall of bladder to get the area information of bladder section. It calculates the volume of bladder by volume integral algorithm on the basis of the area information of 12 reference planes which are changed automatically with an interval of 15°. MD-6000 Bladder Scanner has a Pre-Scan function, which shows the real-time B mode image for sectional plane of bladder. The Pre-Scan function helps a user to locate the bladder easily and get more accurate results. Built-in thermal printer provides convenience of printing data.
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