Deepsight NeedleVue LC1 Ultrasound System

The DeepSight NeedleVue LC1 Ultrasound System is a general-purpose diagnostic ultrasound device mounted on a movable cart for imaging adult and pediatric patients. It is intended for abdominal, pediatric, small organ, peripheral vascular, fetal, urological, and musculoskeletal conventional and superficial imaging by qualified healthcare professionals in hospitals, clinics, and other medical settings.

The device includes three functional blocks: a front end with a single curved array transducer and analog signal processing; a back end with touchscreen interface, memory, USB export, and LCD display; and power systems. It operates in 2D B-mode with harmonic imaging capability, uses 120 VAC power, and features beamforming on both transmit and receive sides with digital reconstruction and processing.

IEC 62304 (software lifecycle), IEC 60601-1-2 (EMC), IEC 60601-1 (general safety), IEC 60601-2-37 (ultrasound safety), IEC 62359 (thermal and mechanical indices), IEC 62127-1 and 62127-2 (hydrophones and acoustic field measurement). FDA guidance documents on diagnostic ultrasound, device software, EMC, cybersecurity, and reprocessing were also cited.

The subject device and predicate (GE LOGIQ E9) are both general-purpose diagnostic ultrasound systems with identical intended uses and substantially equivalent indications. Both operate on the same three functional principles (front end, back end, power systems), use the same power source, and employ identical beamforming and processing architectures. Although the predicate supports more imaging modes and transducer types, these differences do not raise different safety or effectiveness questions and do not introduce new functionalities. Performance testing demonstrates comparable safety and effectiveness profiles between the two systems.