Genoray's CBCT 'GT300' Receives ANVISA Certification in Brazil (2025.08.21)

Global X-ray diagnostic equipment manufacturer Genoray (CEO Park Byung-wook) drew attention on the 21st by announcing that its CBCT product, the GT300, has received ANVISA (Brazil) certification. The GT300 is a CBCT launched in 2024 based on Genoray's in-house production capabilities, and since its release, it has obtained MFDS (Korea) and N...

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GENORAY
December 26, 2025
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Global X-ray diagnostic equipment manufacturer Genoray (CEO Park Byung-wook) drew attention on the 21st by announcing that its CBCT product, the GT300, has received ANVISA (Brazil) certification.

The GT300 is a CBCT launched in 2024 based on Genoray's in-house production capabilities. Since its release, it has expanded its market presence by sequentially obtaining MFDS (Korea) and NRTL (North America) certifications. With the completion of registration with ANVISA (Brazil), which is known for its rigorous certification process, the GT300 is now set to accelerate its expansion into the Latin American market.

The GT300 is a dental CBCT used for orthodontic diagnosis and dental check-ups, and it had already captured market attention through demo requests at exhibitions even before its official launch. By manufacturing and producing all core components in-house, the company has not only enhanced the product's durability and stability but also upgraded features and specifications such as Large FOV (Field of View) and Smart Positioning to ensure operator convenience and cost-effectiveness. Equipped with a Large FOV, it captures a wide area in a single scan, which can then be selected according to the specific size required for each examination. Furthermore, 'Smart Positioning' allows for the retrieval of visit records for returning patients, supporting rapid and convenient customized check-ups.

Founded in 2001, Genoray is performing well in the global market, led by its five overseas subsidiaries. In early August, the company also received FDA 510(k) clearance for its mammography system, HESTIA. Beyond this, Genoray has been recognized for its proven product quality and service, achieving a series of milestones including: receiving the Bronze Tower Order of Industrial Service Merit and a Presidential Commendation on Trade Day; being selected as a Leading Innovative Enterprise by the Ministry of Health and Welfare; and being chosen for the 2025 Jump-Up Program.

A Genoray representative stated, "This certification is the result of 25 years of refining our proprietary technology and expertise," adding, "We will dedicate our full efforts to new product development and providing customized customer service to dominate the global market."