High-intensity focused ultrasound (HIFU) has been in clinical use for a variety of solid tumors and cancers. Accurate and reliable calibration is in a great need for clinical applications. An extracorporeal clinical HIFU system applied for the investigational device exemption (IDE) to the Food and Drug Administration (FDA) so that evaluation of its characteristics, performance, and safety was required.

中文翻译：

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体外高强度聚焦超声 (HIFU) 系统的表征和体外评估

高强度聚焦超声 (HIFU) 已在临床上用于多种实体瘤和癌症。临床应用非常需要准确可靠的校准。体外临床 HIFU 系统向食品和药物管理局 (FDA) 申请了研究器械豁免 (IDE)，因此需要对其特性、性能和安全性进行评估。