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Medical Devices / Submissions and Approvals

Agfa Receives 510(k) Clearance for Imaging System

March 12, 2019

Agfa received 510(k) clearance from the FDA for its DR 800, a multipurpose imaging system that offers radiography, fluoroscopy, tomography and other advanced clinical applications.

The image processor is equipped with software for better brightness control, enhanced noise suppression and veiling glare reduction.

The device includes software that processes the tomographic slices it generates from a tomographic sweep and can reconstruct images in less than a minute.

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