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

Epica International, a leader in advanced imaging solutions and industrial robotics, is thrilled to announce that its cutting-edge See Factor CT3™ System has received an updated 510(k) clearance from the U.S. Food and Drug Administration (FDA). This landmark achievement underscores Epica International’s commitment to revolutionizing high-resolution CT imaging for human point-of-care applications, particularly in operating rooms. The latest clearance reflects significant enhancements made to the device since its original 2019 release, empowering Epica International to market and distribute the newly upgraded See Factor CT3™ across the United States.

Empowering Healthcare Professionals: The See Factor CT3™ now boasts unparalleled mobility and multi-modality capabilities, featuring an innovative indexing gantry designed to deliver high-resolution, orthogonal, and three-dimensional CT images for diverse clinical applications. This advanced imaging technology enables clinicians to conduct computed tomography, fluoroscopy, and digital radiography in any adequately shielded location, eliminating the need to transport patients. With its onboard DICOM viewer, images can be reviewed by the treating physician within minutes, enhancing diagnostic and treatment efficiency.

Indications For Use: The See Factor CT3™ is a flat-panel cone beam computed tomography X-ray imaging system designed for acquiring detailed images of the head, neck, and limbs in adult patients. It also captures images of portions of the thorax, spine, and pelvic bones, focusing on high x-ray attenuation areas such as bony structures. With a 62.5cm gantry bore and a 30cm field of view, the device provides 2D and 3D imaging for both intra-operative and clinical use. Additionally, it is capable of acquiring digital radiography and fluoroscopy images, operated by physicians, x-ray technologists, and other qualified professionals.

Key Features of the See Factor CT3™ System:

  • High-Resolution Imaging: Exceptional image clarity and detail down to 0.1mm (100 microns), ensuring precise diagnostics.
  • Mobility: Requires no extensive infrastructure to house, cool, or power large, fixed scanning equipment—only adequate lead shielding.
  • Multi-Modal Capabilities: Integrates various imaging modalities into a single, flexible platform.
  • User-Friendly Interface: Intuitive design promotes ease of use for healthcare professionals, reducing training time and boosting efficiency. Onboard viewer allows bedside image review.
  • Compact and Versatile Design: Perfectly suited for a wide range of clinical settings, from large hospitals to small clinics.

Joe Soto, CEO of Epica International, Inc., remarked, “This is another significant achievement by Epica's regulatory team. These additional indications for use further illustrate our technology's expanding capabilities.”

About Epica International, Inc.:

Epica International is a global leader in advanced medical imaging and precision robotics, serving human, animal, and industrial markets worldwide. Epica designs, develops, and distributes proprietary advanced medical imaging platforms and cutting-edge robotic systems that enhance user accuracy and outcomes. The company holds 75 issued and pending patents on its medical imaging and robotics platforms in the U.S., EU, and other countries. Epica International is headquartered in Landrum, SC.

For more information on Epica International, please visit our website at www.epicainternational.com.

For more information on the See Factor CT3™, please visit our website at www.epicahumanhealth.com.

For further inquiries on this clearance and business development, please contact:

Ben Hill
Epica International, Inc.

Craig Glaiberman, MD
Chief Medical Officer
Epica International, Inc.

Source: Epica International, Inc.