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510(k) Data Aggregation

    K Number
    K070845
    Device Name
    SOUNMED COLOPOSCOPE COLPO-99/99PLUS
    Manufacturer
    SOUNMED, INC.
    Date Cleared
    2007-10-12

    (199 days)

    Product Code
    HEX
    Regulation Number
    884.1630
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOUNMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sounmed Colposcope COLPO-99 is intended to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy.
    Device Description
    The ColposcopeS COLPO-99 / 99 PLUS is a precise optical instrument designed specially for the gynecologic examination. The Sounmed colposcope can be used to view vaginal en cervical tissues using stereoscopic optics. The COLPO-99/ 99 PLUS Colposcope has detailed features that include a wide field of view, long focal length, uniform illumination, adjustable brightness, ease operation, and exceptional optics. It is an essential instrument for any gynecologic examination. The general features of the device are as follows: Eyepiece Magnification: 12.5X with diopter adjustment. Focal Length: 300mm. Green filter light. Easy replacement of halogen light bulb. Ball joint gives you 360 degree easy motion for gross focus.
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    K Number
    K071156
    Device Name
    SOUNMED SD-2000 PLUS PORTABLE ULTRASOUND SCANNER
    Manufacturer
    SOUNMED, INC.
    Date Cleared
    2007-07-03

    (69 days)

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

    SOUNMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or fluid flowd analyisis of the human body as follows: - Fetal-OB/GYN - Abdominal - Small Organs (breast, thyroid, testicle) - Trans-Vaqinal - Trans-Rectal Typical examinations performed using the system are: - General abdominal and pelvic studies including organ surveys, assessment, and retroperitoneal cavity studies. - Study of small parts and superficial structures including breasts, shoulders, thyroid, and the abdominal wall. - First, second and third trimester pregnancy studies. - Prostate, bladder and rectum visualization.
    Device Description
    The Sounmed SD-2000 Plus (KX2000G) is a black and white mobile diagnostic ultrasound imaging system. This device is designed to project ultrasound waves into body tissue and to present the returned echo information on the monitor. Operating Modes of SD-2000 Plus (KX2000G) are B, B/B, B/M, and M. The Sounmed SD-2000 Plus (KX2000G) supports a selection of Linear and Convex probes for wide variety of application. It is an ultrasound scanner, which provides high resolution, high penetration, and various measurement functions. Probes are supported in frequencies from 3.5 MHz to 7.5 MHz.
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