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510(k) Data Aggregation

    K Number
    K101181
    Device Name
    BEL-CAT
    Date Cleared
    2011-07-19

    (448 days)

    Product Code
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    TAKARA BELMONT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This is an x-ray device (cone beam computed tomography) that acquires a single 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists. Not for mammographic use.
    Device Description
    The Bel-Cat series is a set of arm type X-ray CT diagnostic devices which has exposure modes can be customized to meet a wide variety of diverse diagnostic imaging needs. The Bel-Cat series is a true all-in-one system capable of offering diverse acquisition modes that deliver the high-definition images demanded in dental fields.
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    K Number
    K093240
    Device Name
    BELRAY II
    Date Cleared
    2010-03-22

    (158 days)

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

    TAKARA BELMONT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BELRAY II, Model 097 is a extraoral source dental radiographic x-ray unit. This unit works as a diagnostic purpose x-ray source for human teeth with the resultant image recorded on intraoral dental x-ray film or image receptor.
    Device Description
    extraoral source dental radiographic x-ray unit
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    K Number
    K072574
    Device Name
    ALPHARD CONE BEAM CT, MODEL X178
    Date Cleared
    2007-10-18

    (35 days)

    Product Code
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    TAKARA BELMONT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Alphard Model X178 is an x-ray device (cone beam computed tomography) that acquires a single 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists.
    Device Description
    Alphard series 3D X-ray CT realizes wide area imaging by adopting the principle of cone beam CT and using high-resolution wide area flat panel detector (FPD). Alphard series enables dentist to take wide range imaging from small area to wide area with appropriate imaging mode according to various treatment objects. Combination of advanced FPD (dynamic range: 14bit) and micro focus X-ray tube provides high resolution CT image from soft tissue to hard tissue. Our original software AsahiVision freely displays high picture quality 3D image and MPR image.
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