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510(k) Data Aggregation

    K Number
    K121401
    Device Name
    TENDER TOUCH
    Date Cleared
    2013-05-01

    (356 days)

    Product Code
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOMETECH CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Tender Touch is intended to emit energy in the visible and infrared spectrum to provide heating for the purpose of elevating tissue temperature for the temporary relief of joint pain, muscle stiffness, minor arthritis pain or muscle spasm; the temporary increase in local blood circulation and the temporary relaxation of muscle.
    Device Description
    Not Found
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    K Number
    K024186
    Device Name
    X-VIEW
    Date Cleared
    2004-04-01

    (469 days)

    Product Code
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOMETECH CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The X -- VIEW System is a device used to provide instant images of the human oral tissue and teeth without the use of conventional x-ray films. While an X-Ray machine is still utilized, the acquisition of an image requires up to 90% less radiation than a conventional system would require to produce the same image.
    Device Description
    X View device consists of 3 components: the sensor and its cable, data box, and a PC with sensor adapter. The sensors outer body is made of hermitically sealed polymer shell which encapsulates a black and white CCD. The sensor attaches to the processing unit via a 3 m cable. The outer dimensions are approximately 40 x 25 x 5 mm with rounded edges. The Data box relays the data to the computer for display. The data box is white 4 x 9 inch box with a 5 ft USB cable connection. The X-View System is used to provide instant images of x-rayed human oral tissue and teeth without the use of conventional x-ray films. The sensor, upon radiation exposure, Captures the images into a computer for viewing, storage, and printing The X-View System, along with the aforementioned other systems, consists of a sensor and its cable, a sensor adapter, and a personal computer. The sensor and cable are fully waterproof ( IXP 7 standard ) and may be sterilized by full immersion in a disinfectant solution. The sensor's outer body is made of hermetically sealed polymer shell, which encapsulates a black and white CCD. It has an active sensitive area of 600 mm2, an image matrix of 960,000 pixels and renders a minimum 15 lines / mm and a maximum 18 lines /mm.
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    K Number
    K031436
    Device Name
    MEDISCOPE
    Date Cleared
    2003-12-19

    (227 days)

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

    SOMETECH CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Gynecological and (Obstetrical colposcope MEDISCOPE, Diagnostic Device), is intended for magnified viewing of the tissues of cervix.
    Device Description
    MEDISCOPE, colposcope ( Obstetrical and Gynecological Diagnostic Device ) is a medical camera unit and accessories to be used to magnify and view tissues of the cervix and diagnose abnormalities and select areas for biopsy. Mediscope consists of a main unit ( power source ) and probe. MEDISCOPE is designed for effective communication and education between doctors and patients. MEDISCOPE can be connected to a TV, CCTV, or Color Video Printer.
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