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510(k) Data Aggregation
K Number
K180671Device Name
MINE
Manufacturer
Date Cleared
2019-06-05
(448 days)
Product Code
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
RHT Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MINE is intended to be used by trained dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.
Device Description
MINE, a portable dental X-ray system, operates on 11.1V DC supplied by a rechargeable LiPolymer battery pack, The X-ray tube head, controls and power source are assembled into a single hand-held enclosure. The package includes a battery charger.
The portable X-ray system. MINE, being composed of X-ray generator, controller, and beam limiting device is designed to diagnose tooth and jaw through generated and controlled X-ray. The operating principle of MINE starts from the generation of X-ray by high voltage electricity, which in turn penetrates tooth and jaw area after flowing through X-ray tube and produces X-ray images on X-ray receptors (i.e. chemical film or digital sensor)
This device contains a high frequency inverter that converts direct to alternating current, X-ray tube head, electrical protective devices, and other elements. The MINE produces sharp and clear images and prevents patients and dentists from radiation exposure with utilizing small dose of radiation.
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