Sonosite iLOOK Ultrasound System

The Sonosite iLOOK Ultrasound System is a portable, general-purpose diagnostic ultrasound device consisting of a 10.1-inch tablet display running Android and a wireless L15-5 linear transducer. It is intended for use by qualified physicians and healthcare professionals to perform ultrasound imaging and fluid flow analysis for pediatric, peripheral vessel, and needle guidance applications in medical practices, hospitals, and clinics.

The iLOOK uses the same fundamental ultrasonic pulsed-echo and Doppler technology as the predicate iViz device but with a larger tablet display (10.1 inches vs. 7 inches), wireless transducer connectivity similar to the Vscan Air reference device, and advanced image processing (CViz) derived from the iViz's SonoHD3 feature. Acoustic output meets FDA limits with MI <1.9 and Ispta <720 mW/cm², and the device operates via battery or AC power.

ISO 10993-1 (biocompatibility), IEC 60601-1 (medical electrical equipment basic safety), IEC 60601-1-2 (electromagnetic disturbances), IEC 60601-1-6 (usability), IEC 60601-2-37 (ultrasonic diagnostic equipment), IEC 62304 (software life cycle), ISO 14971 (risk management), and IEC 62359 (thermal and mechanical indices).

The Sonosite iLOOK is substantially equivalent to the Sonosite iViz (K180704) predicate and Vscan Air (K250087) reference device because it performs the same diagnostic ultrasound function, employs identical fundamental scientific technology, shares the same or a subset of indications for use, has equivalent biosafety, and complies with the same medical device safety standards. The differences (larger display, wireless transducer, added needle guidance indication, and advanced image processing) do not alter the basic safety and effectiveness profile.