EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound LLCThe EPIQ Series and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC are advanced diagnostic ultrasound imaging systems used in various clinical settings, including hospitals and clinics. They provide imaging and fluid flow analysis of multiple body regions through modes like B Mode, Doppler, and Harmonic Imaging, helping clinicians diagnose a wide range of conditions. A new Remote Software Management feature enhances workflow by allowing remote software upgrades and maintenance, improving system availability and usability without hardware changes.
Intended Use
Diagnostic ultrasound imaging and fluid flow analysis of the human body across a broad range of clinical indications (e.g. abdominal, cardiac, cerebral vascular, musculoskeletal, small organ, lung) in clinical environments including clinics, hospitals, and point-of-care.
Technology
The device is a diagnostic ultrasound system that supports multiple modes of operation including B Mode, M Mode, Pulsed Wave Doppler, Continuous Wave Doppler, Color Doppler, Power Doppler, and Harmonic Imaging. It features a new Remote Software Management (RSM) that enables remote upgrading of OS packages, device drivers, application packages, and software downloads/installation automatically or on schedule without hardware changes.
Performance
The device underwent design verification including software verification according to IEC 62304 and risk management per ISO 14971, with all tests meeting acceptance criteria. No new clinical data were required as substantial equivalence was established through comparison of features, indications, and technological characteristics to the predicate device. Post-installation verification is performed remotely to ensure settings are retained.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/22/2025
2 months - 2
FDA Approval
4/10/2025
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