Pirox Achieves EU MDR Certification Following FDA 510(k) Clearance

 

Yofo Medical has reached another important milestone in its global development. Following FDA 510(k) clearance for its Dental Cone Beam Computed Tomography System on 17 April 2025, Pirox has now achieved CE certification under the EU Medical Device Regulation (MDR).   On 9 January, TÜV Rheinland formally presented Yofo Medical with its EU MDR certificate, marking another significant step in bringing Yofo's dental imaging technology to international markets.

Yofo Medical receives EU MDR certification  for Pirox from TÜV Rheinland

 

Together, EU MDR certification and FDA 510(k) clearance strengthen the regulatory foundation for Pirox in two of the world's major medical device markets and reflect Yofo's continued commitment to product safety, performance, quality and regulatory compliance.

 

Meeting Regulatory Requirements Across Global Markets

 

Medical imaging systems operate within rigorous regulatory frameworks designed to protect patients and ensure consistent product performance. EU MDR certification and FDA 510(k) clearance represent two important milestones in Yofo's international regulatory development.

 

EU MDR Certification

Meeting European Requirements for Medical Devices

 

The EU Medical Device Regulation (EU) 2017/745 establishes requirements covering areas including device safety and performance, clinical evidence, quality management and post-market surveillance. For applicable device classes, conformity assessment involves an independent Notified Body before CE marking.   Pirox's certification under the EU MDR demonstrates conformity with the applicable European regulatory requirements within its certified scope, providing an important foundation for access to the European market.

Yofo Medical’s EU MDR certificate record in EUDAMED

 

FDA 510(k) Clearance

An Important Milestone for the US Market

 

The FDA 510(k) pathway requires manufacturers to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device for its intended use.   Yofo Medical's Dental Cone Beam Computed Tomography System received FDA 510(k) clearance under K243337 on 17 April 2025. The FDA database classifies the device as a Class II dental computed tomography X-ray system and records a substantially equivalent decision.   This clearance represents an important regulatory milestone for Yofo's development in the US market.

Yofo Medical’s FDA 510(k) clearance record

 

Together, these regulatory milestones reflect the quality and regulatory systems behind Yofo's international development and provide a stronger foundation for bringing its dental CBCT technology to healthcare professionals across global markets.

 

Performance Designed Beyond Conventional CBCT

 

Regulatory progress is supported by the imaging technology and clinical design behind Pirox.

 

Pirox takes a different approach to conventional dental CBCT design. Its top-open, seated configuration creates a more open scanning environment while supporting easier patient positioning and a more comfortable imaging experience.

 

At the core of the system, dual-source parallel scanning enables high-precision, non-fused imaging across a large field of view. Pirox combines broad anatomical coverage, high spatial resolution and lower-dose imaging to support demanding dental and maxillofacial applications.

 

A single scan can also provide multiple imaging views, including CBCT, panoramic and cephalometric images, helping simplify acquisition and support a more efficient clinical workflow.

 

Designed around both imaging performance and the experience of clinicians and patients, Pirox reflects Yofo's approach to advancing dental CBCT beyond conventional limits.

 

A Milestone in Yofo's Global Development

 

EU MDR certification and FDA 510(k) clearance represent more than regulatory milestones. They form part of the infrastructure required to bring advanced medical imaging technology to international markets with consistency and confidence.

 

For Yofo, this progress builds on years of investment in imaging science, engineering, clinical validation and quality systems.

 

As Yofo continues its international development, we will keep advancing precision imaging through clinically driven innovation, rigorous validation and technologies designed to create lasting clinical value.