Device review added: product registration questions and answers!

Q.

As for the accessories used with imaging equipment, one of the series of problems that should be paid attention to in registration and declaration: Can the passive accessories used to support and fix patients be declared together with the equipment?

A.

Passive accessories of CT, MR And other imaging equipment, such as brackets, cushions, supports, fixation belts, fixation frames, fixation plates, etc., which are used to fix and support the patient’s position during the imaging process, can be declared together with

Q.

How should vascular models be selected in the study of endovascular catheter simulation?

A.

The model of the pseudo-vascular anatomical structure should reflect the most challenging vascular anatomical structure in the application range of the product, such as considering lumen diameter, bending radius, bending shape, bending number, vessel length, friction coefficient of the internal surface of the vessel, and the model material.

Source/CMDE