We are proud to announce a significant regulatory milestone: roclub has officially received FDA 510(k) clearance for its Teleoperations Platform. This approval by the U.S. Food and Drug Administration marks a major step forward in our mission to deliver safe, effective, and future-ready solutions for medical imaging operations in the United States.
A Milestone for Safety, Quality, and Trust
The FDA 510(k) clearance confirms that our technology meets the stringent safety and performance standards required for clinical use in the U.S. healthcare market. It validates our platform as substantially equivalent to legally marketed reference products in terms of safety, effectiveness, and intended use.
For healthcare providers and partners, this certification offers an added layer of confidence in the quality and reliability of the roclub Teleoperations Platform. It ensures that radiology departments, clinics, and hospitals can adopt our solution knowing it aligns with U.S. regulatory requirements.
Commitment to Excellence and Compliance
This achievement is more than a regulatory formality—it is a reflection of roclub’s dedication to product integrity, user safety, and compliance. The clearance follows a rigorous review process, assessing both technical and clinical aspects of the platform. It also reinforces our commitment to responsible innovation and our ability to operate in highly regulated environments.
Looking Ahead: Expanding Impact Across the U.S.
With FDA clearance now in place, roclub is poised to expand its footprint in the U.S. and collaborate with a wide range of healthcare providers to support advanced, decentralized imaging services. Our Teleoperations Platform is designed to enable remote operation of imaging systems across sites and vendors, improving access, efficiency, and patient care—especially in underserved or resource-constrained regions.
We would like to extend a heartfelt thank you to our regulatory, development, and quality teams, as well as to our partners and clients whose trust and support helped us reach this important milestone.