Vatech receives FDA approval for two digital panorama machines
Digital medical device company Vatech (CEO: Chang-Joon Ro) announced on the 15th that 2 digital panorama machines including “PaX-Uni 3D Basic” and “PaX-Uni 3D” received FDA approval.
Such was realized through “SUNI Medical Imaging” via a request for FDA approval in America for products under the OEM (original equipment manufacturing) supply agreement last July 16.
At this time, “SUNI 3D (model name in America)” -- which was customized according to the medical situation in America -- was approved.
“Vatech requests for FDA approval for these 2 models directly to export them as its own brand rather than through OEM. If we receive FDA approval, our sales in the foreign market particularly the American market will increase rapidly,” the official revealed earlier.
As the supplier of Vatech, SUNI Medical Imaging is a specialized supplier of medical devices in America. Boasting of an international sales network, it has produced and sold I/O sensor, I/O camera, and X-ray application software in Silicon Valley and enjoyed high reliability in the American market through high-quality products.
“Based on this FDA approval, we shall develop as an international brand of dental medical devices not only in the American but other overseas markets as well,” an official at Vatech said.