www.fdanews.com/articles/192953-epica-grabs-fda-clearance-for-tomography-imaging-system
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Epica Grabs FDA Clearance for Tomography Imaging System
October 3, 2019
The FDA granted 510(k) clearance to Epica International’s SeeFactorCT3 imaging platform, a device that combines three different imaging systems.
The robotically-controlled platform includes CT, fluoroscopy and digital radiography imaging systems, a detachable patient table and chair, and a sterile drape used for interventional procedures.
The ultra high-resolution system can be moved to patients in an intensive care unit or emergency room and can be operated by physicians, surgeons, dentists, or other qualified professionals.