Sonosite LX Ultrasound System

The Sonosite LX Ultrasound System is a general-purpose diagnostic ultrasound device for qualified physicians and healthcare professionals. It acquires and displays real-time ultrasound data in multiple modes (B-mode, M-mode, Pulsed Wave Doppler, Continuous Wave Doppler, Color Power Doppler) for evaluation of abdominal, cardiac, fetal, musculoskeletal, and other anatomical regions. The system is designed as an integrated kiosk-style unit with a 21.3-inch touch screen and supports prescription use only in medical facilities and clinics.

The device shares the same fundamental ultrasound technology as the primary predicate (Sonosite LX K233597), with identical 128/128 beamformer channels, 128 digital transmit and receive channels, and identical imaging modes. The main addition is the new UHF46-20 ultra-high-frequency transducer (1.0–46.0 MHz) that extends the frequency range slightly above the predicate's 1.0–19.0 MHz while remaining within the reference device's 1.0–70 MHz range. Acoustic output (Ispta.3: 607 mW/cm²; MI: 1.72; TI: 4.87) remains identical to the predicate, with MI and TI values always displayed and managed to stay within FDA derated limits.

ISO 10993-1:2018 (biocompatibility); IEC 60601-1:2005 (general electrical safety); IEC 60601-1-2:2014 (electromagnetic compatibility); IEC 60601-1-6:2013-10 (usability); IEC 60601-2-37:2015 (ultrasonic diagnostic equipment); IEC 62304:2006/A1:2016 (software lifecycle); ISO 14971:2019 (risk management); IEC 62359:2017-09 (thermal and mechanical indices for ultrasound).

Substantial equivalence is established because the Sonosite LX uses identical intended use (diagnostic ultrasound imaging), shares the same fundamental scientific technology and operating modes as the predicate, and has equivalent acoustic output and safety performance. The new UHF46-20 transducer is substantially equivalent to the UHF48 transducer previously cleared on the reference device (Vevo MD K190476), and the dermatological indication is an extension of the predicate's superficial and vessel exam types already cleared on Vevo MD. All patient-contact materials are biocompatible, the device meets all applicable FDA-recognized safety standards, and clinical testing confirmed the device performs as expected.