Meridian's digital imager gets FDA nod

PACS and x-ray system provider Meridian Medical Systems has received U.S. Food and Drug Administration (FDA) clearance to market its Monarch ultrahigh-definition (UHD) Universal Digital Imager (UDI) with wireless detector and automatic exposure detection (AED).

The clearance includes the Monarch UDI 2 and the Monarch UDI 2 with wireless/AED. The system has been cleared for use in both pediatric and adult radiographic imaging.

Meridian's Monarch UDI 2 with UHD is specified to operate as a certified component when used with the Meridian Operators Console to control x-ray generators and other acquisition and display parameters, the firm said. The Monarch UHD is used with a 20-inch acquisition console that features 3,840 x 2,560 display resolution, four times that of typical acquisition stations.

AED senses the x-ray and automatically acquires the image without requiring a wired connection to the generator, enabling Monarch UHD to be used on any new or existing x-ray capable system.

The waterproof design of the 20-inch mobile tablet operators' console enables it to withstand the wipe downs required to maintain 100% sanitation compliance, Meridian added.

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