Owandy gets FDA clearance for 3D imaging system
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Owandy gets FDA clearance for 3D imaging system

Owandy gets FDA clearance for 3D imaging system

Owandy Radiology has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its I-Max 3D wall-mounted, panoramic digital radiography unit.

The unit includes multiple fields-of-view and four volume sizes. It is equipped with 3D software for case planning and can share stereolithography (STL) files from a dental lab or a digital scanner for CAD/CAM processes.

The unit weighs 145 lb, is recommended for endodontics with a 5 x 5-cm volume, and includes the company’s automatic layers integration system for image quality and selection.

Owandy will feature the system at the upcoming Greater New York Dental Meeting.

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