What kinds of medical devices do CT machines belong to?

CT machine belongs to three kinds of medical instruments.

The third category of medical devices is:

Medical devices used for implanting or maintaining life are potentially dangerous to human body, and their safety and effectiveness must be strictly controlled. Such as implantable pacemakers, extracorporeal shock wave lithotripsy, invasive patient monitoring systems, intraocular lenses, invasive endoscopes, ultrasonic scalpel, color ultrasound imaging equipment, laser surgical equipment, high-frequency electrotome and microwave therapeutic apparatus.

Medical magnetic resonance imaging equipment, X-ray therapy equipment, X-ray machines over 200mA, medical high-energy equipment, artificial heart-lung machines, internal fixation equipment, artificial heart valves, artificial kidneys, respiratory anesthesia equipment, disposable sterile syringes, disposable infusion sets, blood transfusions, CT equipment, etc.

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Extended data:

List of materials required to apply for Class III medical devices:

(a) a copy of the business license and organization code certificate;

(2) A copy of the registration certificate and product technical requirements of the medical devices produced by the applicant enterprise; ?

(3) Copies of the identity certificates of the legal representative and the person in charge of the enterprise;

(four) the identity, education and title certificate of the person in charge of production, quality and technology;

(5) List of academic qualifications and titles of employees in production management and quality inspection positions;

(six) the production site certification documents, if there are special requirements for the production environment, it shall also submit a copy of the facilities and environmental certification documents;

(seven) the main production equipment and inspection equipment directory;

(eight) quality manuals and program documents;

(9) Process flow chart;

(10) authorization certificate of the agent;

(eleven) other supporting materials.

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