Clarius Ultrasound Scanner
Clarius Mobile Health Corp.The Clarius Ultrasound Scanner is a portable, wireless ultrasound imaging system designed for diagnostic use across multiple body regions. It connects via Wi-Fi to mobile devices, allowing healthcare professionals to visualize real-time, high-resolution ultrasound images and fluid flow analysis in diverse clinical applications such as fetal, abdominal, cardiac, musculoskeletal, and more. This device facilitates medical imaging in varied clinical environments by enabling image acquisition on tablets and smartphones.
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body across multiple clinical applications including ophthalmic, fetal, abdominal, intra-operative (non-neurological), pediatric, small organ, cephalic, trans-rectal, trans-vaginal, musculo-skeletal, urology, gynecology, cardiac (adult, pediatric), peripheral vessel, carotid, and guidance of needles into the body.
Technology
The system consists of wireless ultrasound transducers that communicate via Wi-Fi Direct and Bluetooth to an external iOS or Android mobile device. The transducer includes a battery, multichannel beam former, pre-scan converter, and Wi-Fi components. The piezoelectric transducer emits non-ionizing ultrasound waves and receives echoes to generate digital images displayed on personal devices.
Performance
Performance testing demonstrated compliance with required safety and effectiveness standards including electrical safety, electromagnetic compatibility, usability, biological evaluation, software lifecycle processes, and acoustic output standards. Clinical testing was not required to support substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/27/2018
1 month - 2
FDA Approval
5/14/2018
Other devices from Clarius Mobile Health Corp.
- Clarius OB AI2024 • 510K
- Clarius Bladder AI2023 • 510K
- Clarius Ultrasound Scanner2023 • 510K
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