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The D-RS AT Digital Dynamic Remote System Is indicated for use in generating fluoroscopic images of human anatomy for diagnostic procedures. It Is intended to replace fluoroscopic images obtained through image intensionaly. Not intended for mammography applications.

The D2RS AT Digital Dynamic Remote System is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Trixell Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography and is detachable and portable for direct projections to create a unique and highly versatile 3-in-1 imaging solution. The receptor panel directly converts the X-ray images captured by the sensor into a high-resolution digital images. The instrument is suited for use inside a patient environment. This unit converts the X-rays into digital signals. The unit can acquire still and moving images. The system includes a remotely controlled tilting/elevating table. Panel information: Based on a flat-panel digital detector with the largest field-of-view in the market, the Pixium RF 4343 FL is designed for easy integration in classical R&F tables. It allows manufacturers to offer radiologists an all-digital real-time system, generating high-quality images for both routine dynamic applications and high-end static ones. Digital technology facilitates the work of X-ray technicians and speeds up the process, allowing medical centers to optimize patient throughput. Universal: a single detector for both Radiography and Fluoroscopy. An optional static panel may be added to the system: Trixell Pixium 3543EZ. The 3543EZ panel has already been cleared in various 510(k)s including K131314 and K141440. That panel is not mounted and can be moved around by the technician. The system must always have either the Pixium RF 4343, Pixium RF 4343FL for the system to be able to perform fluoroscopy. These fluoroscopic panels were not to our knowledge previously cleared by FDA, so complete performance information as requested by the FDA guidance document on solid state x-ray panels has been provided.