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Carestream Digital Tomosynthesis Receives FDA Clearance

ROCHESTER, N.Y., Jan. 14 — Carestream’s Digital Tomosynthesis (DT) functionality—a three-dimensional extension of general radiography—has received 510(k) clearance from the U.S. Food and Drug Administration.

Simplifying workflow and reducing exam time, DT technology is an upgradable option on the CARESTREAM DRX-Evolution Plus System (see video link), a versatile digital radiography system that can perform a wide range of general radiographic exams.

Digital Tomosynthesis uses a single sweep of X-ray exposures and streamlines operator workflow by separating the process of DT exposure acquisition from image volume formation. As a result, it can generate data from a series of low dose X-ray images of the same organ, taken at the same X-ray exposure, from different angles.

“The images captured by Digital Tomosynthesis technology offer greater depth and enhanced visualization,” said Sarah Verna, Worldwide Marketing Manager for Global X-ray Solutions at Carestream. “Doctors and radiologists will be able to perform scans quickly, providing valuable clinical information for further diagnosis while improving the workflow in an
X-ray room.”

Digital Tomosynthesis, like a computed tomography (CT) scan, can produce cross-sectional images of an organ, allowing for increased visibility. This capability enhances the DRX-Evolution Plus in situations where physicians need quick answers.

“In trauma centers, CT rooms are always overbooked and there’s always a wait,” Ms. Verna said. “Now a doctor can further examine any body part, including the chest or lungs, with Digital Tomosynthesis because it generates many image slices, which helps sharpen diagnosis and make medical treatment more efficient. Digital Tomosynthesis does not replace computed tomography and can be used in conjunction with it.”

Carestream customers will now have the option to purchase the DT software for their DRX-Evolution Plus systems. Coupled with the company’s new ImageView Software that is powered by the Eclipse image processing engine, the DRX-Evolution Plus with Digital Tomosynthesis transforms into a powerful digital imaging tool for hospital systems.