EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

The EPIQ and Affiniti Series Diagnostic Ultrasound Systems are diagnostic imaging devices that perform ultrasound imaging and fluid flow analysis across multiple clinical applications including abdominal, cardiac, obstetric, gynecological, musculoskeletal, and peripheral vessel imaging. They operate in B Mode, M Mode, Doppler modes, Color Doppler, and Harmonic Imaging, and are used in clinics, hospitals, and point-of-care settings by trained healthcare professionals.

The key technological change is the addition of a Remote Software Management (RSM) feature that enables remote upgrade of major software releases (OS packages, device drivers, BIOS/UEFI, application packages) with automatic and scheduled download/installation capabilities. Previously, only patch upgrades via manual navigation were supported. No hardware changes or new transducers are required; existing commercialized Philips transducers are used. The feature is supported on EPIQ and Affiniti models running software version 12.0.

The device was tested in accordance with IEC 62304 (Medical Device Software – Software Life Cycle Processes, 2006 + A 2015) and ISO 14971 (Medical Devices – Application of Risk Management to Medical Devices). The devices comply with the FDA Ultrasound Guidance Document: Guidance for Industry and FDA Staff – Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (February 2023).

The proposed device is substantially equivalent because it maintains identical classification (Class II), product code (IYN), and regulatory framework (21 CFR 892.1550) as the predicate K242020. The indications for use, intended users, use environments, and fundamental diagnostic functionality remain unchanged. The RSM enhancement is a workflow improvement that expands remote update capabilities from patches only to include full software releases with automated scheduling, but does not alter the core diagnostic imaging performance, safety profile, or clinical functionality. All verification and validation testing met acceptance criteria, demonstrating that the software enhancement does not introduce new safety or effectiveness concerns.