Digital Radiofluoroscopy Table System Receives FDA Clearance

A universal digital radiofluoroscopy (R/F) table system is designed to perform a wide range of examinations, including endoscopy, angiography, video fluoroscopy for gastrointestinal series and swallowing exams, orthopedic exams, and general radiography.

Shimadzu Medical Systems, USA (Torrance, CA, USA;) has announced that the Sonialvision G4 universal digital R/F table system has received 510(k) clearance from the US Food and Drug Administration (FDA). The system expands Shimadzu’s product range with the addition of the advanced system that has received strong acceptance in Europe and Asia.

The technology acquires high image quality images rapidly and uses low radiation dose levels. Its new ergonomic design is patient safety- and hygiene-focused, accommodates all sizes of ambulatory and stretcher/wheelchair confined patients, and offers workflow-efficiency features to help improve technologist productivity.

The system combines a 17-inch x 17-inch flat panel detector (FPD) with Shimadzu’s next- generation digital imaging platform. Its 139 μm ultra-small pixel pitch and high contrast maximizes the FPD performance. Its easily switchable large-to-small fields-of-view cover a range of imaging from finger tips to the entire chest or abdomen. Furthermore, the wide 202.5 cm movement range of the Sonialvision G4 can capture images of the complete body without moving the patient.

Various real-time digital filtering processes effectively suppress halation near skin surfaces and around shadows where organs overlap. Smoother imaging is achieved with no delay or image lags by applying optimal digital filtering and extracting noise components. Used in long spine and limb imaging, Shimadzu’s Slot Beam functionality is available as an advanced application option. With its lower dose profile, the Slot Beam is an excellent choice for pediatrics.

The Sonialvision G4 is equipped with a wealth of functions to facilitate urological exams. The edge of the imaging range can be positioned as close as 9.5 cm from the head end of the table, given a 17-inch field-of-view, making it easy to perform procedures using an optical endoscope. It is also possible to tilt the table without changing an observation position. A specialized collimation function helps reduce dose.

An oblique projection function prevents overlapping organs when performing gastrointestinal examinations. Fluoroscopic images can be saved in Digital Imaging and Communications in Medicine (DICOM) format. Patients in wheelchairs can be examined easily by extending the imaging chain, which has a maximum 15 cm per second quick movement.

The Sonialvision G4 supports angiography procedures with its streamlined design, and its large field of view enables digital subtraction angiography (DSA) to be used for exams ranging from the hepatic artery to the entire lower extremities. Special features for every type of exam the system performs help to minimize radiation dose exposure levels to the patient. A table that can support a patient weighing up to 317.5 kg in the horizontal position for bariatric procedures is designed for easy cleaning and integrates safety features to facilitate safe access and egress by patients.

This new system design of the G4 also provides productive and comfortable workflow to optimize convenience and operability for the technologists who use it. Its high-speed dual-processor can simultaneously resolve images, register patient data, and perform other functions rapidly without interfering with the examination being performed. The number of operating steps a technologist needs to perform during an examination is substantially reduced because the R/F table, X-ray generator, and digital processor are linked.

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Shimadzu Medical Systems USA