24 August 2021

---

Surround Medical wins FDA 510(k) for PORTRAY™

Katherine E. Pfaff

---

Surround Medical Systems, Inc. received FDA 510(k) pre-market clearance for the 2D diagnostic system, PORTRAY Dental Imaging System. The devices are expected to be available within the fourth quarter and will be prepared and shipped from the North Carolina facility. 

Under the clearance, PORTRAY can be used as a 2D diagnostic tool, as well as to utilize additional diagnostic capabilities, including 2D synthetic and 3D tomosynthesis imaging to create radiographs of the jaw, teeth, and mouth. The advancement could improve cavity detection compared to x-rays by providing imaging of early tooth decay and improved detail to see additional dental issues. 

"Dentists have been waiting for a major improvement to intraoral dental imaging for more than two decades," said David LaVance, president and CEO. "The PORTRAY system provides dentists with an intraoral 3D dental imaging system that will allow the dentists to provide a higher level of care for patients by detecting cavities and fractures that would otherwise go undetected by current 2D intraoral dental imaging systems. The PORTRAY system has the potential to substantially change and improve dental techniques and provide patients better outcomes and improved health."

PORTRAY was developed based on carbon nanotube technology that was built on x-ray methodology. The discoveries were made by the University of North Carolina at Chapel Hill researchers. 

Source: https://www.prnewswire.com/news-releases/surround-medical-systems-announces-fda-510k-pre-market-clearance-of-the-portray-dental-imaging-system-301352512.html