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Samsung’s subsidiary gets 510(k) approval for its GC85A DR system

Samsung Electronics subsidiary NeuroLogica has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its GC85A digital radiography (DR) system.


Samsung GC85A is a ceiling digital X-ray system, which is claimed to provide streamlined workflows, diagnostic confidence and improved total cost of ownership.

NeuroLogica global sales vice-president and chief marketing officer David Webster said: "The Samsung GC85A represents NeuroLogica’s latest commitment to introducing user- and patient-centric innovation to healthcare to provide fast, easy and accurate diagnoses.

"The system’s superior image quality and ease of control will enable users to experience a new level of efficiency with a DR system designed for streamlined operation."

The new DR system features S-Vue imaging engine, wireless and lightweight S-Detector, smart control, smart stitching, S-Align and S-Share compatibility.

Samsung’s other DR systems include mobile digital GM60A U-arm digital GU60A and ceiling digital GC80.

NeuroLogica also produces products such as CereTom for brain imaging, inSPira HD for bedside imaging and BodyTom, a full body 32-slice CT scanner with an 85cm gantry.

Image: NeuroLogica obtains FDA approval for GC85A DR system. Photo: courtesy of NeuroLogica Corporation.