Clarius Ultrasound Scanner
Clarius Mobile Health Corp.The Clarius Ultrasound Scanner is a portable, software-controlled ultrasound system that connects wirelessly to iOS or Android devices to provide high-resolution, real-time diagnostic ultrasound and Doppler imaging. It supports multiple clinical applications such as abdominal, cardiac, musculoskeletal, fetal, and procedural guidance, helping clinicians perform ultrasound imaging conveniently in diverse healthcare settings.
Intended Use
Diagnostic ultrasound imaging and fluid flow analysis in multiple clinical applications including ophthalmic, fetal, abdominal, intra-operative (non-neurological), pediatric, small organ, cephalic (adult), trans-rectal, trans-vaginal, musculo-skeletal, urology, gynecology, cardiac (adult, pediatric), peripheral vessel, carotid, and procedural guidance of needles.
Technology
The system consists of wireless transducers communicating via Bluetooth and Wi-Fi with off-the-shelf iOS or Android devices. It provides high-resolution real-time ultrasound and Doppler imaging modes including B-mode, M-mode, color Doppler, power Doppler, and pulsed wave Doppler. The product comes in multiple models with varying transducer types such as convex, linear, phased array, and intracavity probes.
Performance
The device met all relevant standards for electrical safety, electromagnetic compatibility, usability, ultrasonic diagnostic equipment performance, battery safety, software lifecycle, and biocompatibility. Clinical testing was not required for equivalence. Quality assurance followed FDA QSR 21 CFR 820.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/5/2019
24 days - 2
FDA Approval
8/29/2019
Other devices from Clarius Mobile Health Corp.
- Clarius OB AI2024 • 510K
- Clarius Bladder AI2023 • 510K
- Clarius Ultrasound Scanner2023 • 510K
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