Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6)

The Readius L15, P8, V6, and C6 are general-purpose diagnostic ultrasound imaging systems intended for use by trained physicians in hospital or clinical settings. They perform ultrasound evaluation of abdominal, small organs (thyroid, testes, breast), and peripheral vascular applications using B-Mode, M-mode, Color Flow Map, Vector Space Flow, Color Power Angio, Pulsed Wave, and Panoscope imaging modes.

The Readius devices use WiFi to transmit image signals from the ultrasound probe to a handheld device (iOS or Android) for display, differing from the predicate Apogee 2300 which used a traditional console-based system. However, the imaging principles, imaging modes, image magnification, acoustic power levels, probe materials, and transducer designs are the same as the predicate device. All four Readius models share identical hardware and safety-critical components but differ in probe configurations based on market positioning.

IEC 60601-1:2005+AMD, IEC 60601-1-2:2014+AMD1, IEC 60601-2-37:2007+A1, IEC 60601-2-25:2011, IEC 62304:2006+A1, IEC 60601-1-6:2010+AMD, IEC 62366-1:2015+AMD1, ISO 14971:2019, ISO 10993 series (parts 1, 5, 10, 23), ISO 13485:2016, ISO 15223-1:2021, and FDA guidance on premarket submissions for software in medical devices and diagnostic ultrasound systems.

The subject devices are substantially equivalent to the predicate Apogee 2300 because they maintain identical imaging principles, modes, and technical performance despite the operational difference of WiFi-based wireless display. The acoustic power levels, probe materials, transducer designs, and all safety-critical components are the same as the predicate. Although the subject devices have fewer indications than the predicate, the restricted indications represent a subset of the predicate's uses and do not introduce new safety risks. Non-clinical testing demonstrates compliance with all applicable standards, and the differences in form factor and display method do not affect safety or efficacy.