GENORAY Completes FDA 510(k) Clearance for Digital Mammography System 'HESTIA' (2025.07.28)

GENORAY announced on the 28th that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its breast imaging system, 'HESTIA.'

Following the launch of HESTIA, GENORAY has secured certifications from the MFDS (Korea), CE MDR (Europe), PMDA (Japan), and ANVISA (Brazil). With this latest FDA clearance, the company is now expanding its sales reach into the Americas, building on its existing presence in Korea, Europe, Japan, and Brazil.

HESTIA is a mammography system that captures images of internal breast tissue to diagnose lesions, including cancer. With the global emphasis on the effectiveness of early diagnosis and the steady annual growth of the breast cancer screening and diagnostic market in the Americas, GENORAY expects to accelerate its market penetration in the region, led by HESTIA.

The company stated, "HESTIA is a product that enables three-dimensional diagnosis of micro-lesions such as masses and calcifications by incorporating not only 2D imaging but also Tomosynthesis-based 3D imaging. It was the first in Korea to introduce Tomosynthesis functionality and minimizes radiation exposure through the application of an Auto Collimator." They added, "Beyond its technology and features, it has also been highly regarded for its aesthetic design, winning the '2020 Good Design' award."

With approximately 25 years of experience, this global export company received the Bronze Tower Order of Industrial Service Merit on Trade Day last year and has achieved a series of successes, including the extension of its Innovative Medical Device Company (Leading Type) certification and selection for the Jump-Up program.

A GENORAY representative said, "The FDA certification for HESTIA is a result that cements GENORAY's technological and manufacturing prowess on the global stage," adding, "We will continue to deliver our superior technology to the world, paired with customized services for our customers."