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510(k) Data Aggregation

    K Number
    K031802
    Device Name
    CORIX 70 PLUS-USV
    Manufacturer
    Date Cleared
    2003-07-21

    (40 days)

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

    CORAMEX, S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The indication for use of the Corix 70 Plus-USV (with DPM timer) is extra oral The melodelen for use in dentistry as required for the radiographic examination and diagnosis of the dental anatomy.
    Device Description
    Corix 70 Plus-USV is a Dental X-Ray generator; its primary use is for intra oral image receptor radiology. For such application, a peak voltage of 70 kVp has been demonstrated to give a high quality film with a good film quality/risk ratio. This is also enhanced by the fact that the tube current has the value of 8 mA, assuring effectiveness. The soft X-Ray are filtered by the inherent filtration and by an additional filter to guarantee the minimum 2 mm eq. of Al required by specifications. Exposure times are microprocessor controlled, assuring a high constancy and also repeatability. The high voltage generator is enclosed in a cover. The beam-limiting device is formed by a circular cone with a maximum diameter of 60 mm. The weight of the tubehead is 7.5 kg. The certified components may be assembled in different configurations in terms of arms and mounting. The control box assembly and the timer are combined as one and include all the electronics to power the high voltage transformer contained on the tubehead. plastic prismatic cover. X-Ray exposures are signaled by both acoustic and optical signals. The operator may choose exposure times ranging from 0.03 up to 3.00 seconds.
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