The author recently learned from Mianyang Food and Drug Administration that the oral X-ray digital tomography equipment (CBCT, also called dental CT) developed by Sichuan Jiujiu Tianmu Medical Devices Co., Ltd. has undergone strict national expert review and technical review. , obtained the three types of medical device registration certificate from the State Food and Drug Administration.
CBCT is the most promising and practical device in today's oral cranial imaging equipment. The application of CBCT has revolutionized the diagnosis and treatment of oral and cranial clinical fields. The business of oral implants and the needs of cosmetic surgery It will further lead to the explosive growth of CBCT. The US ADA expects to have at least 100,000 markets worldwide in the next five years.
Under the arrangement of the municipal party committee and the municipal government, the Municipal Food and Drug Administration will coordinate, guide and assist the company's product R&D registration and declaration work from the end of 2012. The leaders of the provincial bureaus and relevant departments have given strong support from the establishment of the production quality management system to the clinical application and the preparation of the application materials, guiding the enterprises to scientifically and standardize the preparation of pre-registration materials as soon as possible, and actively communicating with the State Administration of Foreign Affairs to help coordinate the review process. The problem has greatly shortened the product approval cycle.
Sichuan Jiujiu Tianmu Medical Devices Co., Ltd. is a high-end medical device R&D and manufacturing enterprise established by the Chinese Academy of Medicine and Sinopharm Group Tianmu Pharmaceutical Co., Ltd., relying on the research and development platform of the Chinese Academy of Sciences and the National X-ray Digital Imaging Instrument Center, fully integrating the cooperative enterprises, Stomatological hospital and other unit superior resources, the first phase of the use of authorized patent military technology, has developed oral X-ray digital tomography equipment for nearly 5 years, the product through the international original reconstruction algorithm, equipped with visualization application software, to reach the patient's three-dimensional Image accurate imaging, clinical imaging diagnostic compliance rate reached the international level of similar high-end products, registration declaration successfully broke the technical barriers and price monopoly of foreign companies on China's high-end medical devices.
Usb Microscope,Digital Microscope Display Screen,Lcd Screen Digital Microscope,Digital Lcd Display Microscope
NINGBO VANCO INSTRUMENT CO.,LTD , https://www.vancoscope.com