Search Results

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.

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.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of diagnostic performance or clinical effectiveness. The document provided is a 510(k) premarket notification review for the Rextar Pro, an extraoral source X-ray system, and focuses primarily on establishing substantial equivalence to a predicate device (REXTAR X, K132041) based on technical characteristics and safety standards.

The document discusses non-clinical performance testing for safety and electrical compatibility, specifically referencing:

• IEC 60601-2-65: Particular requirements for basic safety and essential performance of dental intra-oral X-ray equipment.
• IEC 60601-1: General requirements for basic safety and essential performance.
• IEC 60601-1-2: Electromagnetic disturbances—requirements and tests.
• FDA software guidance: Content of Premarket Submissions for Device Software Functions.
• Leakage Radiation Test: Measurements made at 15 different points around the device.

The conclusion states that the REXTAR PRO's radiation emitting level at the operator's perspective is fairly minimal compared to NCRP requirements (occupational radiation exposure to adults working with radioactive material to 5,000 mR (50 mSv) per year).

However, none of the requested information regarding diagnostic performance (e.g., sensitivity, specificity, AUC), sample sizes for test sets, expert qualifications, ground truth establishment for diagnostic evaluation, or MRMC studies are present in the provided text. The document confirms the device is intended for "producing diagnostic x-ray images using intraoral image receptors" but does not detail how the diagnostic quality or effectiveness of these images by the Rextar Pro itself was assessed against specific acceptance criteria.

Ask a specific question about this device