Rextar Pro
Raypia Co., LtdThe Rextar Pro is a portable, handheld extraoral X-ray device designed for use by trained dentists and dental technicians to produce diagnostic X-ray images using intraoral image receptors. It is a battery-powered high-frequency X-ray generator with specialized shielding to minimize radiation exposure to users. This lightweight and compact device helps clinicians obtain high-quality dental images conveniently and safely.
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.
Technology
Portable, handheld extraoral X-ray generator with a high frequency ripple-free HF type generator (70 kV / 2 mA output). Features include touch screen control, rechargeable battery, use of high purity lead shielding, backscatter shield to minimize user exposure, and a specialized 0.2 mm focal spot GRID tube to improve image quality.
Performance
The device was tested to applicable IEC standards including IEC 60601-2-65 for dental intra-oral X-ray equipment and FDA software guidance. Leakage radiation tests showed operator radiation exposure is below occupational limits even at high usage levels. The device is substantially equivalent to its predicate with no new safety or effectiveness concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/25/2024
4 months - 2
FDA Approval
12/4/2024
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