Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLCThe Philips EPIQ and Affiniti Series systems are advanced diagnostic ultrasound platforms used by healthcare professionals to capture and analyze real-time ultrasound images of the human body. Recent software updates improve image quality, workflow efficiency, and remote consultation features, helping clinicians make more accurate and timely diagnoses across a wide range of clinical settings.
Intended Use
Diagnostic ultrasound imaging and fluid flow analysis of the human body across multiple anatomical regions and patient age groups.
Technology
General-purpose, software-controlled ultrasound devices that use FDA-cleared transducers and support conventional imaging modes. The software update introduces usability and image quality refinements, remote tele-ultrasound access, and workflow automation without changes to hardware or fundamental imaging architecture.
Performance
Software verification, validation, risk management, and non-clinical performance testing were conducted according to IEC 62304, IEC 62366-1, and ISO 14971. No clinical investigations were required for this update. All updates were evaluated for safety and effectiveness, and system performance was confirmed via established design control activities.
Predicate Devices
No predicate devices specified
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