Lumify Diagnostic Ultrasound System
Philips UltrasoundThe Lumify Diagnostic Ultrasound System by Philips Ultrasound is a mobile, software-controlled ultrasound imaging device that supports various imaging modes including B-mode, Color Doppler, Pulsed Wave Doppler, and M-mode. It is designed for diagnostic ultrasound imaging and fluid flow analysis across many anatomical areas such as fetal, abdominal, musculoskeletal, cardiac, ophthalmic, and more. The device is compatible with iOS and Android systems and includes different USB transducers. The recent update adds an ocular preset to enable ophthalmic imaging, expanding its clinical utility. This portable ultrasound system helps clinicians obtain high-resolution images and flow data to support diagnosis and procedural decisions.
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, and M modes across multiple clinical applications including fetal, abdominal, pediatric, cardiac, musculoskeletal, ophthalmic, and more. It is a transportable ultrasound system intended for use by healthcare professionals.
Technology
The Lumify Diagnostic Ultrasound System is a mobile, software-controlled device that operates on iOS and Android platforms using commercially available smartphones or tablets. It uses USB transducers (curved, linear, and sector arrays) and supports multiple ultrasound imaging modes. The recent addition includes an ocular preset for ophthalmic imaging available with the L12-4 linear transducer.
Performance
The device underwent non-clinical verification and validation testing including software lifecycle processes, usability engineering, and risk management. Performance testing confirmed that the device meets all safety and effectiveness criteria without introducing new risks. Clinical performance data was not required for this update as equivalence was demonstrated through technological and functional comparisons with predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/5/2024
8 months - 2
FDA Approval
5/8/2025
Other devices from Philips Ultrasound
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.