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510(k) Data Aggregation

    K Number
    K063472
    Device Name
    ULTRASONIC BIOMETER/ PACHYMETER FOR OPHTHALMOLOGY, MODEL ODM 2100, 2200
    Manufacturer
    MEDA LTD.
    Date Cleared
    2007-01-31

    (77 days)

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

    MEDA LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ODM-1000A/P intended used for ophthalmology to accurately measure the axial length (AL), anterior chamber depth (ACD), lens thickness (LT), and corneal thickness (CT). The ODM-1000A intended used for ophthalmology to accurately measure the axial length (AL), anterior chamber depth (ACD), lens thickness (LT). The ODM-1000P intended used for ophthalmology to accurately measure the corneal thickness (CT). Ultrasound Imaging of the Eye Axial biometric parameter measurement of the Eye
    Device Description
    ODM-1000 A/P Biometer is an ultrasonic measuring instrument of pulse reflection. It contains two independent units: A-Mode Axis Biometric Parameter Measuring Unit and P-Mode Corneal Thickness Measuring Unit. It can be selected by user to configure: ODM-1000A Ultrasonic A-Biometer (only for axial A biometry) ODM-1000P Pachymeter (only for corneal thickness measurement) The A-Biometer consists of a 10MHz A-probe and biometric unit. The axial biometry is the measurement for anterior chamber depth (ACD), lens thickness (LENS), vitreous length (VITR) and axial length (AL). Corneal thickness Pachymeter consists of a 20MHz-pachymetric probe and the measuring unit. It is on the basis of the measurement of time interval between the anterior and post interface reflection wave to get the thickness of the cornea. The ODM-1000A/P includes A-mode axial biometric parameter measurement and P-mode Corneal thickness measurement. Users can switch between these two modes through keyboard. In A-mode, the 10MHz transducer transmits ultrasound into eye tissue and receives its echo reflected back by anterior chamber, lens and vitreum. Each length and their sum (AL) are calculated by measuring the time spent in different parts. In P-mode, the 20MHz transducer transmits ultrasound into eye tissue and receives its echo reflected back by the anterior and post interface reflection pulse of the cornea, and then measure the time interval between two reflection pulse to get the thickness of the cornea.
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    K Number
    K063433
    Device Name
    ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 2200
    Manufacturer
    MEDA LTD.
    Date Cleared
    2007-01-29

    (77 days)

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

    MEDA LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the ODM-2100 & ODM-2200 includes the location and visualization of ophthalmic disorders and measurement of ocular distances. Ultrasound Imaging of the eye. Axial biometric parameter measurement of the eye. Diagnostic ultrasound imaging
    Device Description
    The ODM-2100/2200 combines a B-scanner used for the visualization by ultrasound of the eye and orbit and an A-scan used for intraocular measurements. The intended used of this system includes the localization and visualization of ophthalmic disorders and measurement of the eye and orbit. The ODM-2200 uses the same software and hardware (Switch power supply, P.C. board, user's interface, transducer etc.) as ODM-2100 does. The only difference is that: ODM-2100 uses a portable housing and built-in 10-inch video monitor; ODM-2200 uses standard SVGA. LCD monitor. The ODM-2100/2200 includes B-mode ultrasonic cross-section imaging and A-mode axial biometric parameter measurement. Users can switch between these two modes through keyboard. In B-mode, the 10MHz transducer emits ultrasound under electric pulse and then receives and stores its echo reflected by interfaces of different tissues. Through the sector scanning of transducer, several echo lines create real time image of eye tissue and the image is displayed on the monitor. In A-mode, the 10MHz transducer transmits ultrasound into eye tissue and receives its echo reflected back by anterior chamber, lens and vitreum. Each length and their sum (AL) are calculated by measuring the time spent in different parts.
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