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Fujifilm Medical Systems obtains FDA 510(k) approval for X-ray detectors

Fujifilm Medical Systems U.S.A., a provider diagnostic imaging products and medical informatics solutions, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Gadolinium and Cesium digital X-ray detectors for pediatric use.

The X-ray detectors are available in 24x30cm, 14×17 and 17×17 sizes.

The 24x30cm cesium iodide detector is specifically designed to offer high detective quantum efficiency (DQE) performance for low dose x-ray exams such as for small patients and anatomy such as extremities, shoulders, c-spines and more.

Fujifilm Medical Systems Digital X-ray director of marketing and product development Rob Fabrizio noted the company has always been committed to patient safety and it continues set a high standard in establishing safe, low-dose pediatric imaging.

"We have helped lead the way with our commitment to reducing radiation and investing in new imaging technology innovations that allow us to offer a safe and effective imaging for every size patient and anatomy.

"With this clearance, radiologists, technologists and administrators can count on Fujifilm to bring quality images for fast, confident diagnoses for our most precious patients; infants and children," Fabrizio added.