Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series)

The Ultrasound Imaging System is a portable, software-based ultrasound device that runs on commercial mobile devices (tablets/smartphones) and communicates wirelessly via Wi-Fi. It includes three product series (LX, 128, LU700) with multiple transducer models and supports B-mode, M-mode, Doppler, and color flow imaging for a broad range of diagnostic ultrasound applications including fetal, cardiac, musculoskeletal, and interventional guidance.

The LX Series introduces dual-headed probes (LX128LC, LX128LP, LX192LC) combining linear, convex, and phased-array elements in a single probe housing. The 128 and LU700 Series retain single-headed probe designs. All three series use the same core software architecture, wireless communication via IEEE 802.11 a/b/g/n, Li-ion rechargeable batteries, and comply with IEC 60601-1 Edition 3.2 and IEC 60601-1-2 Edition 4.1 safety standards.

IEC 60601-1 Edition 3.2 (2020), IEC 60601-1-2 Edition 4.1 (2020), IEC 60601-1-6 (usability), IEC 60601-2-37 (ultrasonic diagnostic equipment), IEC 62133-2 (battery safety), AIUM/NEMA UD 2 & UD 3, ISO 10993 series (biocompatibility), ISO 14971 (risk management), ISO 62304 (software lifecycle), and ISO 13485 (quality management).

The LX Series maintains identical software, cover materials, and transducer specifications as the predicate 128 Series while replacing a single PCB with a dual-headed probe design. Acoustic output testing, biocompatibility, and cleaning/disinfection effectiveness all meet FDA requirements and show no adverse effects. The same clinical applications apply across all three series. Since the technology, safety standards compliance, and operating modes are established and proven in the predicate device, the addition of this alternative probe form factor with equivalent performance and specifications creates substantial equivalence without requiring additional clinical testing.