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510(k) Data Aggregation
K Number
K160458Device Name
BI IMAGE-X EVOLUTION
Manufacturer
Date Cleared
2016-06-20
(122 days)
Product Code
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
RADIOTECNOLOGIA INDUSTRIAL S.A. DE C.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BI IMAGE-X EVOLUTION device is an X-Ray generator designed for radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure in combination with an intraoral image receptor.
Device Description
The device is designed to be used by dental professionals for radiographic examinations to assist with diagnosis of diseases of the teeth, jaw, and oral structure by exposing an x-ray image receptor to ionizing radiation. The x-ray source, a tube, is located outside the mouth. All three conventional types of intraoral receptors can be used with this device: analog x-ray film, digital phosphorous plates, and digital x-ray sensors. The Bi Image-X Evolution is a wall mounted device or can also be a floor model on a stand.
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