Epica International has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its SeeFactorCT3 multi-modality and mobile computed tomography imaging platform.

SeeFactorCT3 platform is comprised of three integrated imaging systems, including CT, fluoroscopy and digital radiography. It is provided with a detachable patient table/chair and sterile drape for interventional procedures.

SeeFactorCT3 offers ultra high-resolution 3D volumetric images

SeeFactorCT3 is a diagnostic, interventional and intraoperative imaging platform designed to provide ultra high-resolution 3D volumetric images, as well as full featured fluoroscopy and digital radiography.

The system offers non-interpolated image data and delivers isotropic image resolution as fine as 0.1mm in both soft and hard tissue. It also facilitates lesion detection as small as 0.2mm, while the company’s pulsed technology will help reduce the radiation dose received by the patient and healthcare professionals.

Epica’s SeeFactorCT3 platform uses dynamic flat panel sensor technology, which captures sequences of the head such as the ear, nose, and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw and temporo-mandibular joint (TMJ).

The system also acquires the sequences of other areas of human skull and neck with sections of upper cervical spine, and upper and lower extremities for use in diagnostic and intraoperative support.

Designed to be used by physicians, surgeons, dentists, imaging technologists and other legally qualified professionals, the SeeFactorCT3 platform holds the capacity to show 2D and 3D images for each examined anatomical region.

The lightweight and ultra-high resolution SeeFactorCT3 imaging platform can be placed near a patient in ICU, ER/Trauma areas, imaging room or operating room.

Epica International CEO Frank D’Amelio said: “I am very pleased to announce this major milestone event in Epica’s history; our progression into the human medical space.

“I thank Epica’s employees for their commitment to bringing this technology to the human medical market. Having obtained this FDA 510(k) clearance for our SeeFactorCT3™, we will now increase our development focus on our Medical Robot, the integration of our CT imaging platform with our surgical assist robotic arm.”

In September, GE Healthcare secured 510(k) clearance from the FDA for its Critical Care Suite of artificial intelligence (AI) algorithms embedded on a mobile X-ray device.