CT MRI falls into several categories of medical devices

CT machines belong to the third class of medical devices.

The third class of medical devices are:

Medical devices that are used for implantation in the human body or to support life-sustaining, are potentially dangerous to the human body, and must be strictly controlled for their safety and effectiveness. Such as implantable pacemaker, extracorporeal shock wave lithotripsy machine, patient invasive monitoring system, intraocular lens, invasive endoscope, ultrasound scalpel, color ultrasound imaging equipment, laser surgery equipment, high-frequency electrosurgical knife, microwave ** instrument.

Medical MRI equipment, X-ray equipment, X-ray machine above 200mA, medical high-energy equipment, artificial heart-lung machine, internal fixation equipment, artificial heart valve, artificial kidney, respiratory anesthesia equipment, disposable sterile syringe, disposable infusion set, blood transfusion set, CT equipment, etc.

Magnetic resonance imaging Class III medical devices, Class 6832.

Hello landlord, CT is a medical device product belonging to three categories, and it must be handled if you want to sell it.

Vascular machines and CT are both Class III medical devices, and they are also Class B large-scale devices.

To operate these two types of medical devices, it is necessary to first obtain the "Medical Device Business License" issued by the State Food and Drug Administration, which stipulates that several types of medical devices can be operated within the business scope of this certificate.

At the same time, it is also necessary to obtain the "Business License of Enterprise Legal Person" and the authorization letter for operating products.

Vascular machine CT should be of three categories. Register the company first and then apply for a medical device business license before you can operate.

As far as I know, the right to operate large-scale imported medical equipment has not been released. The import and export companies of the three major ports in Tianjin, Shanghai and Guangdong are responsible for the operation of the import and export rights of the three major ports during the planned economy period.

6830 Medical X-ray Equipment.

Serial No. 4 X-ray computed tomography (CT) equipment management category

Examples of product names X-ray head CT machine, whole body CT machine, spiral CT machine, spiral fan scan CT machine.

Class III medical devices are medical devices that are potentially dangerous to the human body and must be strictly controlled.

NMR is included mainly because of the strong magnetic field.

NMR itself is not a radiation hazard to the average human being, but it is noisy. And then there are the strong magnetic fields, which are dangerous for some people with implantable medical devices, such as patients with pacemakers.

In addition, it can be dangerous to carry metal products into strong magnetic fields, so operators need to be trained in safety and strictly control who enters the MRI.