发布时间：2020-10-07

在提交注册申请三个月时间内，AcuSee手术导航系统即成功取得美国食品药品管理局（FDA）颁发的FDA (510)k注册证。

AcuSee系统用于增强对介入针体或针状刚性器械(如活检针，抽吸针，消融针等)的超声成像， 预测器械行进轨迹，并将该轨迹与医用超声成像系统的B-scan图像融合显示于同一屏幕内。该 系统可用于目前由超声进行可视化的术式。该系统应在医疗环境中使用。

The AcuSee system is indicated for augmenting the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or ablation needle, and for predicting its future path on a display, which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in procedures where ultrasound is currently used for visualization.

The AcuSee system is intended to be used in a clinical setting.