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510(k) Data Aggregation
K Number
K031802Device Name
CORIX 70 PLUS-USV
Manufacturer
Date Cleared
2003-07-21
(40 days)
Product Code
Regulation Number
872.1800Why 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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