Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series)
Leltek Inc.The Ultrasound Imaging System (LU700, 128, and LX Series) by Leltek Inc. is a portable, software-controlled ultrasound system that runs on commercial mobile devices. It uses wireless transducers communicating over Wi-Fi to acquire and display real-time, high-resolution ultrasound images across multiple modes such as B-mode and Doppler modes. It aids clinicians in evaluating various body regions and conditions by providing versatile imaging capabilities tailored for different probes and clinical applications.
Intended Use
The Ultrasound Imaging System is a software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals who have the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body.
Technology
The device is a portable, software-controlled handheld ultrasound system using wireless transducers communicating via Wi-Fi with commercial off-the-shelf mobile devices. It incorporates a built-in battery, multichannel beamformer, prescan converter, and software running as an app for real-time ultrasound image acquisition and display.
Performance
The device complies with applicable safety and performance standards, including acoustic output, biosafety, and electromagnetic compatibility standards. It underwent testing that showed no practical detriments, meeting all essential requirements without additional clinical testing needed.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/8/2024
7 months - 2
FDA Approval
5/8/2025
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