Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler Ultrasound Imaging System (Apogee C2); Digital Color Doppler Ultrasound Imaging System (Apogee C3); Digital Color Doppler Ultrasound Imaging System (Apogee C5); Digital Color Doppler Ultrasound Imaging System (Apogee K1); Digital Color Doppler Ultrasound Imaging System (Apogee K2); Digital Color Doppler Ultrasound Imaging System (Apogee K3); Digital Color Doppler Ultrasound Imaging System (Apogee K5); Di

The Apogee series (C1, C2, C3, C5, K1, K2, K3, K5, U1, U2, U3, U5) are multi-purpose digital color Doppler ultrasound imaging systems intended for use by trained healthcare professionals in hospitals or clinical settings. They support a wide range of diagnostic ultrasound applications including fetal, abdominal, cardiac, vascular, and musculoskeletal imaging, as well as multiple imaging modes (B-mode, M-mode, color flow mapping, pulsed/continuous wave Doppler, 3D/4D, elastography, and tissue harmonic imaging).

The subject devices use identical hardware design and the same safe critical components, circuit modules, and working principles as the predicate Apogee 2300. Key technical features—including operation principle, operation controls, system setup, operation modes, measurement, calculation, and file management—are the same as the predicate. Acoustic power levels meet FDA limits identical to the predicate. The subject devices add Contrast Harmonic Imaging (CHI) with liver as a new application site, and introduce seven new probe models (V6LF, C5LF, C6LF, ECBP, ECBP-5, L14LC, P5FC) while other probe models remain consistent with the predicate except for model suffix changes.

Compliance demonstrated with IEC 60601-1:2005 (general safety), IEC 60601-1-2:2014 (electromagnetic disturbances), IEC 60601-2-37:2007 (ultrasonic equipment safety), IEC 60601-2-25:2011 (electrocardiographs), ISO 14971:2019 (risk management), ISO 10993 series (biocompatibility), IEC 62304:2006 (software life cycle), IEC 62366-1:2015 (usability), ISO 13485:2016 (quality management systems), and FDA guidance on software in medical devices and diagnostic ultrasound clearance.

The devices are substantially equivalent to the Apogee 2300 predicate device because they maintain identical hardware architecture, the same safe critical components, and the same fundamental technical operation across all essential features. The addition of Contrast Harmonic Imaging and liver application, along with new probe models, do not raise new safety risks since all applications fall within the predicate's established indications for use and acoustic power remains within FDA limits. Non-clinical testing confirms compliance with all applicable safety and performance standards, and the devices perform comparably to the predicate in terms of technical features, general functions, and applications.