Boston Imaging’s Mobile Digital Radiography Device Gets FDA Clearance

Samsung subsidiary Boston Imaging’s GM85 Fit digital radiography device has received the FDA’s 510(k) clearance.

The device, which features a lithium-ion battery that charges within three to four hours, can take up to 550 exposures during 11 hours of use without additional charging. The lightweight device makes it easier for patient positioning by technologists.

It also operates at low noise levels, less than 42 dB, during standby and night mode to avoid disturbing patients.

The GM85 Fit features an upgraded version of Samsung’s S-Vue imaging processing engine, which mitigates halo artifacts surrounding metallic objects to allow for proper visualization of the bone-metal interface. It also reduces dose levels by up to 47.5 percent for adult abdomen imaging and 45 percent for pediatric abdomen imaging, the company said.