News | Mobile C-Arms | March 23, 2021

GE Healthcare Announces 510(k) Clearance of New 3-D Surgical Imaging System

New 3-D/2-D surgical imaging system, OEC 3D, brings precise 3-D and 2-D imaging to surgical suites improving efficiency

GE Healthcare announced 510(k) clearance from U.S. FDA for OEC 3D, a new surgical imaging system capable of 3-D and 2-D imaging. OEC 3D will set a standard for interoperative 3-D imaging with precise volumetric images for spine and orthopedic procedures. This new system combines the benefits and familiarity of 2-D imaging with greater efficiency to increase access and usability to 3-D.

GE Healthcare

March 23, 2021 — GE Healthcare announced 510(k) clearance from U.S. FDA for OEC 3D, a new surgical imaging system capable of 3-D and 2-D imaging. OEC 3D will set a standard for interoperative 3-D imaging with precise volumetric images for spine and orthopedic procedures. This new system combines the benefits and familiarity of 2-D imaging with greater efficiency to increase access and usability to 3-D.

“We’re thrilled to introduce OEC 3D to clinicians who want amazing 3D volumetric images quickly during intraoperative procedures,” said Gustavo Perez Fernandez, president and CEO of GE Healthcare Image Guided Therapies. “Built on the successful OEC Elite C-arm platform, the familiar performance and functionality of the OEC 3D C-arm will make 3D imaging routine for complex spine and joint replacement procedures.”

Developed in collaboration with healthcare professionals and institutions around the world, OEC 3D C-arm recently completed clinical evaluations in vivo and in simulated laboratory procedures. Clinicians involved commented on the excellent image quality of the 3-D volumes stating they were similar to what they expect from a CT scan. Additionally, the simplicity of performing both 3-D as well as 2-D imaging on OEC 3D was noted as an improvement versus current methods. In a recent study1, during a procedure with a 3-D C-arm, users noted that a second 2-D C-arm is also used 70 percent of the time due to ease of use and familiarity. The OEC 3D C-arm enables users to enjoy the benefits of both 3-D and 2-D imaging in one easy-to-use system.

Revealing a new standard of interoperative imaging, OEC 3D provides a large 19 cm x 19 cm x 19 cm field of view with high resolution and detail. An advanced reconstruction engine quickly presents images on an intuitive Volume Viewer with advanced tools and analysis for surgical assessment. In addition, OEC 3D is open to interface with advanced intraoperative technologies such as navigation and robotics.  

For improved asset utilization, OEC 3D includes the recognizable 2-D imaging experience of OEC C-arms for imaging versatility from general surgery to interventional cardio-vascular procedures, delivering a familiar user experience with the added benefit to quickly capture a 3-D scan.

For more information: www.gehealthcare.com

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