EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

The EPIQ and Affiniti Series Diagnostic Ultrasound Systems are diagnostic imaging devices used for ultrasonic imaging and fluid flow analysis across multiple clinical applications including abdominal, cardiac, obstetric, vascular, and musculoskeletal imaging. These systems operate in B Mode, M Mode, Doppler (PW, CW, Color), and Harmonic Imaging modes, and are intended for use by trained healthcare professionals in clinics, hospitals, and point-of-care settings.

The proposed device introduces a Custom Electromagnetic Interference (EMI) Filter as an optional spare part to reduce electrical noise from external hospital environments and power supplies. This filter provides cleaner electrical signals to the ultrasound system, reducing image artifacts and distortions caused by poor grounding or external electromagnetic interference. The filter does not change the user interface, software performance, indications for use, or fundamental operation of the systems.

IEC 60601-1-2:2014 + AMD1:2020 (General EMC requirements for medical electrical equipment) and IEC 60601-2-37:2007 + AMD1:2015 (Particular requirements for ultrasonic diagnostic equipment). Testing included radiated emissions, conducted emissions, electrostatic discharge immunity, radiated RF immunity, voltage interruptions, and proximity field testing.

The proposed EPIQ and Affiniti systems with Custom EMI Filter are substantially equivalent to predicate K250177 because they have identical indications for use, intended users, clinical environments, device classification (Class II), product codes, and software. The Custom EMI Filter is an enhancement that reduces external electromagnetic interference without introducing new safety or effectiveness concerns, and all EMC testing was successfully passed, confirming the device maintains performance and compliance with applicable standards.