Lumify Diagnostic Ultrasound System
Philips UltrasoundThe Philips Lumify Diagnostic Ultrasound System is a portable medical ultrasound device that allows clinicians to capture high-resolution ultrasound images and analyze blood flow in various body regions. It supports multiple imaging modes and is compatible with mobile devices, helping healthcare professionals perform diagnostic ultrasound in many clinical applications, including obstetrics, gynecology, musculoskeletal, cardiac, and vascular imaging. The addition of the C9-4ec transducer expands its use to trans-vaginal imaging and fertility assessments, improving diagnostic capabilities in reproductive health.
Intended Use
The Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+Color), Pulsed Wave Doppler (PWD), and M-modes in applications including Fetal/Obstetric, Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid, Cardiac, Lung, and Trans-vaginal.
Technology
The Lumify system consists of a mobile software-controlled device compatible with iOS and Android. It includes multiple ultrasonic transducers (C5-2, L12-4, S4-1, and newly added C9-4ec endo-cavitary transducer), USB transducer cables, a power module, and runs Philips Ultrasound software on commercial off-the-shelf (COTS) mobile devices. It acquires high-resolution ultrasounds in B-mode, color Doppler, pulsed wave Doppler, and M modes.
Performance
The device was tested with compliance to standards including IEC 62304, IEC 60601-1 and parts for ultrasound devices, ISO 14971 for risk management, IEC 62366-1 usability engineering, and ISO 10993-1 for biocompatibility. Non-clinical testing demonstrated safe and effective performance. Clinical data was not required due to equivalence with predicate and reference devices. Key performance was validated by design, software, and non-clinical testing.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/23/2024
8 months - 2
FDA Approval
5/15/2025
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