EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

The EPIQ Series and Affiniti Series Diagnostic Ultrasound Systems are diagnostic ultrasound imaging devices with a new Artificial Intelligence (AI) Auto Measure Abdomen software feature that provides semi-automated, editable measurements of abdominal organs such as kidney and spleen to improve workflow efficiency. The systems are used for diagnostic ultrasound imaging and fluid flow analysis across multiple clinical indications including abdominal, cardiac, obstetric, gynecological, and peripheral vascular applications in clinics, hospitals, and point-of-care settings.

The proposed device adds the Auto Measure Abdomen AI software feature to existing EPIQ and Affiniti systems, enabling semi-automated measurement of kidney sagittal length, kidney transverse width, kidney transverse height, and spleen length. The feature is available only on C5-1 and C9-2 transducers and requires software version 14.0 or higher. All other hardware, imaging modes, software architecture, and device classification remain identical to the predicate.

IEC 62304 (Medical device software – Software life cycle processes, 2006 + A 2015), ISO 14971 (Medical devices – Application of risk management to medical devices, 2019), and the FDA Guidance for Industry and FDA Staff – Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (February 2023).

The proposed device is substantially equivalent to predicate K243794 because both are indicated for diagnostic ultrasonic imaging and fluid flow analysis with identical intended users, use environments, device classification, product codes, software architecture, and hardware/imaging modes. The key difference—that Auto Measure in the predicate is for cardiac indication while the proposed Auto Measure Abdomen is for abdominal indication—does not raise new safety or effectiveness questions, as both are software-only changes to previously cleared systems. Performance validation showed the AI algorithm measurements have strong concordance with expert manual measurements across a diverse population.