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510(k) Data Aggregation
K Number
K242185Device Name
Rextar Pro
Manufacturer
Raypia Co., Ltd
Date Cleared
2024-12-04
(132 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
Raypia Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
REXTAR PRO is a portable X-ray system to be used by trained dentists and dental technicians as a mobile, extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. It is intended for adult patients.
Device Description
The REXTAR PRO is an X-ray device offering a lightweight, compact portable X-ray generator. The generator is a high frequency X-ray generator, with a high Output at 70kV / 2mA. The battery-powered device is a Ripple-free HF type of generating device. The REXTAR PRO X-ray function is controlled by Touch Screen and Button for convenience. The handheld device features a main body (X-ray tube head), rechargeable battery (handset), charger, and charger AC/DC power supply. REXTAR PRO uses a high-quality shielding material for shielding (using domestically produced 99.9% purity lead. The RETAR PRO minimizes the exposure of the users from X-ray scattering by adding a backscatter shield. The REXTAR PRO's uses a GRID Tube and is a specialized X-ray tube that improves the quality of the x-ray beam by controlling the flow of electrons through the GRID placed between the cathode and anode. It's application of the Focal Spot 0.2mm GRID Tube for clearer, high-quality imaging helps with the diagnosis for accurate procedures and minimizes patient radiation exposure.
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