Flash Ultrasound System 5100 Point of Care
Philips Ultrasound LLCThe Flash Ultrasound System 5100 Point of Care by Philips Ultrasound LLC is a diagnostic ultrasound system designed for point-of-care use. It offers multimodal ultrasound imaging including B-mode, Doppler, and M-mode for a wide range of anatomical regions and clinical settings, enabling clinicians to perform fluid flow analysis and image diagnostics efficiently in environments like hospitals, emergency rooms, and outpatient clinics. This system helps healthcare professionals make faster and well-informed clinical decisions using advanced ultrasound technology in a compact and user-friendly device.
Intended Use
The Flash Ultrasound System 5100 Point of Care (5100 POC and 5100 POC Pro) is indicated for diagnostic ultrasound imaging and fluid flow analysis of the human body, with indications for abdominal, cardiac, cerebral vascular, fetal/OB, lung, musculoskeletal, neonatal, ophthalmic, carotid, gynecological, pediatric, peripheral vessel, small organs like breast and thyroid, and trans-esophageal and trans-vaginal cardiac imaging.
Technology
The system incorporates assets from the previously cleared 5000 Compact Series hardware platform and a new Rhythm software platform designed for point-of-care use. It features a full touchscreen interface, ergonomic controls, support for multiple transducers, and operates in various ultrasound modes including B Mode, Color Doppler, Pulse Wave Doppler, Tissue Doppler, and M-Mode. The software enhances workflow with features such as assisted needle visualization, flexible patient data management, and AutoStrain EF.
Performance
Performance testing included compliance with multiple IEC and ISO standards related to safety, electromagnetic compatibility, usability engineering, and ultrasound performance. The system underwent non-clinical verification testing addressing system requirements and risk control measures, reporting successful outcomes against pre-determined acceptance criteria. No new clinical data were required given substantial equivalence to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/6/2025
3 months - 2
FDA Approval
4/28/2025
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