Owandy Radiology’s I-Max 3D Receives FDA 510 (k) Clearance

Posted: November 27, 2018
Edited by Dentaltown staff

MIDDLEBURY, Conn.—Owandy Radiology recently received FDA 510 (k) clearance for its 3D wall-mounted panoramic digital radiography unit. The company showcased the product, I-Max 3-D, during the Greater New York Dental Meeting. 

“Thanks to our recent FDA clearance, 3D panoramic digital radiography is now well within the reach of most American dental practices who were previously tight on space and budget," said company spokesperson Boris Loyez.

The I-Max 3-D weighs 145 pounds, is shipped fully-assembled in one box and can be easily wall-mounted by one technician. It also comes equipped with a cone beam flat panel which delivers high-definition image quality.

Other product features include:
• Automatic Layers Integration System (ALI-S) ensures exceptional image quality and automatically selects the best images.
• Multiple fields of view: Four volume sizes to choose from: 12x10 cm ideal for implantology, full mouth and condyle, 9x9cm for a full mouth, 9x5 cm for a full arch. 
• 24 programs (including adult and child versions).
• Includes an intuitive, user-friendly Human Machine Interface (HMI) with automatically-integrated imaging tools and image-enhancing filters.
• CAD/CAM ready: Equipped with QuickVision 3D software for comprehensive case planning and can share .STL files from a dental lab or a digital scanner.

For more information, visit owandy.com, call 203-745-0575 or email sales@owandyus.com.
 
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