Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System
Philips Medical SystemsThe Philips EPIQ and Affiniti Diagnostic Ultrasound Systems are advanced ultrasound machines that provide diagnostic imaging and fluid flow analysis for various body regions. They help clinicians visualize internal organs and blood flow in real time, assisting in the diagnosis and treatment of conditions related to the abdomen, heart, brain, musculoskeletal system, and more. The system also includes liver fat quantification tools to measure attenuation and hepato-renal index, supporting assessment of liver health.
Intended Use
Diagnostic ultrasound imaging and fluid flow analysis of the human body, including multiple specific anatomical regions such as abdominal, cardiac, cerebral vascular, musculoskeletal, and others, used in clinics, hospitals and point-of-care; also assists cardiovascular image guidance when integrated with Philips EchoNavigator.
Technology
Ultrasound-based diagnostic imaging system with software features for liver fat quantification including attenuation coefficient measurement and hepato-renal index ratio quantification; software verification and validation performed to ensure safe and effective measurement; devices utilize pulsed Doppler and pulsed echo ultrasound imaging technologies.
Performance
Performance validation included design control activities such as risk analysis, software verification and validation, non-clinical bench testing comparing attenuation imaging to a predicate device, and adherence to FDA Guidance on software content in medical devices, demonstrating safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/26/2021
29 days - 2
FDA Approval
9/24/2021
Other devices from Philips Medical Systems
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