FDA Clears Shimadzu’s Sonialvision G4 Fluoroscopy System

The U.S. Food and Drug Administration has cleared the Sonialvision G4 X-ray system from Shimadzu Medical Systems USA. The multi-purpose system is intended for orthopedic, angiography, endoscopy, and general purpose radiography work.

The product features a 17-by-17-inch digital detector with a 139 μm pixel pitch and high contrast imaging. The X-ray tube has a more than two meter lateral travel distance, allowing nearly all patients to be imaged from head to toe in one go, according to the company.

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, Slot Beam is an ideal choice for pediatrics, executives noted.

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 DICOM format. Patients in wheelchairs can be examined simply by extending the imaging chain, which has a maximum 15 cm. per second quick movement.

The Sonialvision G4 supports angiography procedures with its wide clean design, and its large field of view enables digital subtraction angiography to be used for examinations ranging from the hepatic artery to the entire lower extremities.

Special features for every type of exam the Sonialvision G4 performs help to minimize radiation dose exposure levels to the patient. A table that can support a patient weighing up to 700 pounds in the horizontal position for bariatric procedures is seamless for easy cleaning and incorporates safety features to facilitate safe access and egress by patients.

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

Shimadzu Medical Systems USA is a subsidiary of Shimadzu Corporation, founded in 1896 in Kyoto, Japan. The company provides medical diagnostic equipment including conventional, interventional, and digital X-ray systems. Shimadzu Medical Systems USA is headquartered in Torrance, Calif., with direct operations headquartered in Dallas, Texas, and sales and service offices throughout the United States, Canada, and the Caribbean.