Dental Tribune USA

Owandy Radiology’s I-Max 3D receives FDA clearance

MIDDLEBURY, Conn., USA: Owandy Radiology, manufacturer of dental radiology hardware and imaging software, recently received FDA 510 (k) clearance for its 3-D wall-mounted panoramic digital radiography unit.

According to Owandy Radiology, when it comes to owning a 3-D panoramic digital radiography unit, cost and physical space are the most common obstacles for many dentists. The I-Max 3D effectively addresses both issues, which is why it is selling briskly in many other parts of the world, the company said.

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

The I-Max 3D provides the perfect balance of price and performance, the company said. For example:

  • The sleek and lightweight I-Max 3-D is only 145 pounds and is shipped fully assembled in one box. It can be easily wall-mounted by one technician.
  • It comes equipped with a cone beam flat panel which delivers high-definition image quality.
  • Automatic Layers Integration System (ALI-S) ensures exceptional image quality and automatically selects the best images.
  • Multiple FOV’s (Fields of View): 4 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.
  • Endodontics Recommended: With its small 5x5cm volume coupled with an excellent resolution of 87μm.
  • 24 Programs (including adult and child versions): Enable a full range of examinations required by today’s dental practice.
  • Includes an intuitive, user-friendly Human Machine Interface (HMI) with automatically-integrated imaging tools and image-enhancing filters.
  • CAD/CAM Ready: Equipped with QuickVision 3-D software for comprehensive case planning and can share .STL files from a dental lab or a digital scanner.
  • Face Features Scan: You can import .PLY or .OBJ files into your 3D software and associate the corresponding 3D volume.
  • Implant surgical guides included.

For more information about the I-Max 3-D wall-mounted panoramic digital radiography unit, visit, call (203) 745-0575 or e-mail Distributors inquiries are always welcome.

(Source: Owandy Radiology)

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