EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound LLCThe EPIQ and Affiniti Series Diagnostic Ultrasound Systems by Philips are advanced ultrasound imaging systems used for a wide range of diagnostic applications across many body regions. The newly introduced Auto ElastQ software feature assists clinicians by automatically selecting the most stable frames and regions of interest for liver stiffness measurements with 2D shear wave elastography, making the diagnostic workflow easier and potentially more reliable. This helps healthcare professionals to assess liver tissue characteristics more efficiently during ultrasound exams.
Intended Use
Diagnostic ultrasound imaging and fluid flow analysis of the human body across multiple anatomical regions including abdominal, cardiac, cerebrovascular, musculoskeletal, small organs, lung, and others. Includes B Mode, M Mode, Doppler modes, Harmonic Imaging, and shear wave elastography (2D-SWE) for liver stiffness.
Technology
The product integrates the Auto ElastQ software feature which automates and recommends frames and ROI placements for liver stiffness measurements using 2D shear wave elastography. The system uses existing Philips transducers (e.g., C5-1) with no hardware changes, runs on EPIQ and Affiniti ultrasound platforms with software version 12.0. The AI-based software analyzes elastography cine loops, automatically selects up to three stable frames, and suggests optimally homogeneous ROI positions to the user, who can accept or adjust them.
Performance
Non-clinical verification testing conformed to IEC 62304 and ISO 14971 standards. Retrospective analysis comparing Auto ElastQ measurements to manual expert measurements showed high agreement, confirming the software accuracy. Predicate equivalence was established without requiring new clinical data. All acceptance criteria were met for software validation and safety.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/11/2024
5 months - 2
FDA Approval
12/12/2024
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