GENORAY's new C-arm 'BELLIGER ACE' receives certifications in Japan and the U.S. (2026.04.07)

GENORAY (CEO Park Byung-wook), a global leader in X-ray imaging diagnostic medical devices, announced on the 7th that its new C-arm, 'BELLIGER ACE', received PMDA approval in Japan on March 30 and FDA 510(k) clearance in the U.S. on April 3.

With these certifications, GENORAY has strengthened its foundation for global expansion, securing approvals in major healthcare markets including Japan and the U.S., following its European CE MDR and domestic certifications. The company explained that it is broadening the base of its C-arm business by systematically accumulating global certifications and market achievements beyond individual product approvals.

GENORAY recently secured CE MDR certification for its entire C-arm product line and is continuing to expand its overseas business, including signing contracts in Brazil and Russia and pursuing tenders in Türkiye. The company also confirmed positive market reception and potential for increased contracts at the Korea International Medical & Hospital Equipment Show (KIMES) 2026.

'BELLIGER ACE', launched in 2025, is a compact entry-level C-arm model designed for enhanced space utilization and operational efficiency. With this certification, the company has demonstrated the competitiveness of its full C-arm portfolio, ranging from premium equipment to compact entry-level models.

A GENORAY representative stated, "The FDA 510(k) clearance and PMDA approval for BELLIGER ACE demonstrate the product's rapid global adoption and reflect our progress in systematically expanding our C-arm business through accumulated global certifications and market success. We will continue to accelerate our expansion into global markets, including the U.S. and Asia, based on the competitiveness of our full C-arm portfolio."