Epica International, Inc. Celebrates FDA 510(k) Clearance for Revolutionary See Factor CT3(TM)

LANDRUM, SC / ACCESSWIRE / June 28, 2024 / Epica International, a leader in advanced imaging solutions and industrial robotics, has announced that its See Factor CT3™ System has received updated 510(k) clearance from the U.S. Food and Drug Administration (FDA). This achievement highlights Epica International's dedication to advancing high-resolution CT imaging for clinical settings, particularly operating rooms. The clearance allows Epica International to market the enhanced See Factor CT3™ across the United States.

The See Factor CT3™ offers unparalleled mobility and multi-modality capabilities. It features an innovative indexing gantry that delivers high-resolution, orthogonal, and three-dimensional CT images. This technology enables clinicians to perform computed tomography, fluoroscopy, and digital radiography without patient transportation. With its onboard DICOM viewer, images can be reviewed within minutes, improving diagnostic and treatment efficiency.

The See Factor CT3™ is designed for detailed imaging of the head, neck, and limbs in adult patients. It also images portions of the thorax, spine, and pelvic bones, focusing on bony structures. With a 62.5cm gantry bore and a 30cm field of view, the device provides 2D and 3D imaging for clinical and intra-operative use. It also acquires digital radiography and fluoroscopy images, usable by qualified professionals.