Digital X-ray System from Samsung Subsidiary Nabs FDA Approval

Danvers, Mass.-based NeuroLogica, a subsidiary of Samsung Electronics Co. Ltd., received U.S. Food and Drug Administration 510(k) clearance for the Samsung GC85A digital radiography (DR) system.

The GC85A expands Samsung’s digital radiography portfolio, which also includes the mobile digital GM60A, the U-arm digital GU60A, and the ceiling digital GC80.

“The Samsung GC85A represents NeuroLogica’s latest commitment to introducing user- and patient-centric innovation to healthcare to provide fast, easy and accurate diagnoses, ” said David Webster, vice president of global sales and chief marketing officer at NeuroLogica. “The system’s 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 GC85A is a ceiling digital X-ray system that offers streamlined workflows, diagnostic confidence and improved total cost of ownership. Features include the S-Vue imaging engine that, according to the company, “provides dependable and accurate diagnoses in various conditions with reliably clear images, enhanced sharpness and clarity, and adjustable contrast presets”; a wireless S-Detector with high detective quantum efficiency and a portable grid that displays the patient’s body structure clearly and easily without increasing dose; Smart Control, which enables the operator to precisely position the entire system with one touch of the control panel’s buttons. The user can move a motorized, tilting receptor with a remote control from -20 to 90 degrees to various areas such as skulls or hands with no need for a table; S-Align, which displays the detector’s angle to the tube head unit (THU) to enhance image quality during free exams. When the THU and detector are within a certain radius, the angle can automatically be fitted; Smart Stitching, which eliminates the need for the patient to stand for long periods of consecutive shooting. Plus, a stitched image supports diagnostic clarity more than separated images; and S-Share Compatibility—S-Detectors are compatible with Samsung DR systems, so when a detector is discharged, it can be used with detectors from other compatible Samsung DR equipment. Various detector configurations support unique clinical needs and continuous care.

NeuroLogica provides computed tomography (CT) design, development and manufacturing, and transforms fixed CT technologies into portable platforms. The company launched CereTom, the first portable CT in 2005. CereTom was designed specifically for brain imaging in critical situations. In 2009, inSPira HD, a portable single-photon emission computed tomography (SPECT) was added to the portfolio bringing SPECT imaging to the bedside. In 2011, using their core imaging expertise, NeuroLogica launched BodyTom, a full-body 32-slice CT scanner with an 85-centimeter gantry. Today, NeuroLogica’s imaging technologies are used in intensive care units, neurosurgical operating rooms, emergency departments, stroke centers and clinics.