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Updated: May 13, 2026

Multimodal Cross-Device and Marker-Free Co-Registration of Preclinical Imaging Modalities
Published on: October 27, 2023
[Clinical trial requests of indigenous diagnostic imaging ultrasound devices in first-time registration application]
Zhaojun Guo1, Guofang Cao, Kan Tao
1Center for Medical Device Evaluation, SFDA, Beijing 100044. guozj@cmde.org.cn
Abstract:
This article introduces the clinical requests of indigenous diagnostic imaging ultrasound devices in first-time registration application and the clinical trial requests in Technical Review Guidance of Ultrasound Imaging Diagnostic Devices (category III) Registration and puts forward some questions of the guidance's implementation. It is hoped to help concerned people.
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Imaging Studies II: Ultrasonography
Ultrasound I: Abdominal Ultrasonography
Abdominal ultrasonography, commonly known as abdominal ultrasound, is a vital, non-invasive medical imaging technique widely used in healthcare.
Procedure:
This diagnostic tool allows the clinician to visually inspect internal structures within the abdomen, including vital organs such as the liver, gallbladder, pancreas, kidneys, and spleen.
The abdominal ultrasound process begins with applying a special gel to the patient's skin over the abdomen. This gel enhances the...