Pirox Receives FDA 510(k) Clearance

On 17 April 2025, YOFO Medical reached an important regulatory milestone as its Dental Cone Beam Computed Tomography System received FDA 510(k) clearance (K243337) from the U.S. Food and Drug Administration.   The FDA database records the device as a Class II dental computed tomography X-ray system and determined it to be substantially equivalent to a legally marketed predicate device. The clearance enables the system to be marketed in the United States, subject to applicable regulatory requirements.

 

What FDA 510(k) clearance means

 

A 510(k) is a premarket submission used to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device in terms of its intended use, safety and effectiveness.

 

For YOFO Medical, the clearance represents an important step in bringing its dental imaging technology to the U.S. market and further strengthening its international regulatory foundation.

 

Pirox: designed around imaging performance and patient experience

 

Pirox combines advanced imaging technology with a distinctive top-open, seated design, creating a more open environment for patient positioning and clinical workflow.

 

The FDA 510(k) summary describes the system as an open design that allows patients to remain seated upright during imaging, with an integrated powered seat for positioning. It also documents multiple imaging fields of view, including a maximum 20 × 18 cm FOV.

 

This combination of imaging capability, system design and clinical usability reflects YOFO Medical’s continued focus on developing precision imaging technologies around real clinical needs.

 

Supporting global expansion

 

FDA 510(k) clearance represents another step in YOFO Medical’s international development and provides an important regulatory foundation for expanding Pirox into the U.S. market.

 

As YOFO continues to build its global presence, the company remains focused on advancing accessible, efficient precision imaging through clinical insight, engineering innovation and long-term product development.

 

Explore Pirox dental CBCT to learn more about its imaging capabilities and top-open seated design.