FDA clears Siemens' Ysio Max DR unit

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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