Mammography Category I and B-ultrasound Category III are medical device classification standards issued by the Ministry of Health (formerly the Ministry of Health) of China. These classification standards provide guidance on the management, registration and supervision of medical devices.
1. Mammography target: Mammography target is a medical X-ray photography equipment, commonly used for imaging examinations of breasts, lungs and other parts. Category I mammography targets refer to medical devices that are classified into a category based on their risk levels when managing and supervising this type of equipment. Class I medical devices have lower risks, generally do not come into direct contact with the human body, and are relatively simple to use.
2. B-ultrasound type three: B-ultrasound is a commonly used medical ultrasound imaging technology, used to examine the shape and structure of the internal organs and tissues of the human body. Class III B-ultrasound refers to medical devices that are divided into three categories according to their risk levels when managing and supervising this type of equipment. Class III medical devices have higher risks, require higher operating personnel during use, and may come into direct contact with the human body.
According to the regulations of the Ministry of Health of China, medical devices are divided into Category I, Category II, Category III and Special Category according to their risk levels. Different levels of medical devices have corresponding requirements and regulations in terms of registration, production, sales and use to ensure their safe and effective use.
It should be noted that the above explanation only applies to China’s medical device classification standards. Other countries may have different classification standards and naming methods. In specific applications, specific operations and management should be carried out in accordance with local laws, regulations and relevant agency regulations.