If Large-scale Imaging Equipment Provides A Third-party Physiological Gating Signal Interface, But Does Not Include Gating Equipment, What Aspects Should Be Considered In The Application Materials?


2022-10-30

For large-scale imaging equipment (such as CT, MR, PET/CT, etc.), if the third-party physiological gating interface is provided, such as respiratory gating interface, ECG gating interface, etc., the administrative counterparts shall specify the relevant requirements of the third-party gating equipment that can be used together in the overview material, such as interface type (including connection mode, data protocol, etc.), standards that shall be met, etc., If the interface is special, the manufacturer, product model, etc. of the equipment that can be used together shall be specified; the verification and validation data tested together with the third-party equipment shall be provided in the research data; the interface type (including connection mode, data protocol, etc.) and the standard (if applicable) shall be specified in the product technical requirements, the technical parameters related to gating shall be tested.