FDA clears Siemens' Ysio Max DR unit

By AuntMinnie.com staff writers

February 26, 2014 -- Siemens Healthcare has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Ysio Max digital radiography (DR) system.

Ysio Max includes Siemens' Multiple Advances in X-ray (MAX) features such as MAXalign, which displays the current detector angle on the system's display screen.

The system also offers three new detectors: MAX wi-D, a 14 x 17-inch wireless detector that weighs 6.6 lb and is 0.7 inches thick; MAX Mini, a 10 x 14-inch wireless detector that weighs 3.5 lb, is 0.6 inches thick, and is designed for use in orthopedics, pediatrics, and trauma exams; and a 17 x 17-inch MAX static detector designed for every patient type, according to the firm.

Ysio Max's Maxswap feature allows use of the MAX wi-D and MAX Mini detectors with other Siemens radiography, fluoroscopy, and urology systems, such as Luminos dRF Max, Luminos Agile Max, and Uroskop Omnia Max, the company said.

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