Epica International, through its subsidiary Epica Human Health, has received the US Food and Drug Administration (FDA) 510(k) approval for expanded use of its SeeFactor CT3.
SeeFactor CT3 is a flat-panel cone beam computed tomography (CT) X-ray imaging system designed to acquire detailed images of the head, neck, and limbs in adult patients.
It also captures images from parts of the thorax, spine, and pelvic bones, focusing on high X-ray attenuation areas such as bony structures.
The imaging system was initially approved in the US, in October 2019, to provide ultra-high-resolution 3D volumetric images, along with Fluoroscopy and Digital Radiography images.
The expanded FDA approval reflects significant enhancements to the system and empowers Epica to market and distribute the upgraded See Factor CT3 system across the US.
Epica International CEO Joe Soto said: “This is another significant achievement by Epica’s regulatory team. These additional indications for use further illustrate our technology’s expanding capabilities.”
According to the company, the healthcare industry is evolving, with a growing demand for precise and versatile imaging solutions.
Its SeeFactor CT3 is designed to address these needs, by providing a sophisticated tool for enhancing diagnostic workflows and patient care.
The upgraded See Factor CT3 system comes with a 62.5cm gantry bore and 30cm field of view, to deliver high-resolution 2D and 3D images.
Its digital radiography and fluoroscopy functions support a wide range of clinical applications, and its image clarity down to 0.1mm (100 microns), ensures precise diagnostics.
The system comes with enhanced imaging capabilities for critical areas, allowing specialists to achieve more precise diagnoses with detailed visualisation of bony structures.
Its superior mobility and multi-modality capabilities will provide high-resolution, orthogonal, and 3D CT images for different clinical applications.
The updated See Factor CT3 will help clinicians conduct computed tomography, fluoroscopy, and digital radiography in any location, eliminating the need to transport patients.
It features an onboard DICOM viewer, which helps the treating physicians review images within minutes, enhancing diagnostic and treatment efficiency.
Furthermore, the system does not require any extensive infrastructure to house, cool, or power large, fixed scanning equipment, except adequate lead shielding.
