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FDA Grants 510(k) Clearance to Samsung's GM85 Fit Radiography Device


Offering enhanced operational capabilities and efficiency, the mobile digital radiography modality reportedly provides improved image quality and software that may help detect pulmonary nodules.

The GM85 Fit (Samsung), a mobile digital radiography device, has garnered 510(k) clearance from the Food and Drug Administration (FDA).

The modality offers a variety of benefits including an ability to take up to 550 exposures during 11 hours of use without additional charging, an ultralight design to promote easy mobility and a lightweight detector, which facilitates patient positioning, according to Boston Imaging, the United States headquarters for Samsung digital radiography and ultrasound systems. Other highlights for the GM85 Fit include low noise levels and an ability to recharge within three to four hours.

A new configuration of the AccE GM85, the GM85 Fit has imaging features such as S-Enhance, which aids in the detection of foreign bodies in the abdomen, chest, and lumbar spine, and SimGrid™, which offers improved quality of non-grid images that is comparable to the quality of grid images. For chest X-rays, the GM85 Fit has a Bone Suppression feature that enables radiologists to suppress the appearance of bones in order to bolster soft tissue clarity.

“As the procedure volume of mobile X-ray increases to deal with unprecedented patient volume, Samsung continues to focus on creating more efficient mobile imaging solutions,” noted David Legg, vice president and head of Boston Imaging.

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