Clarius Ultrasound System
Clarius Mobile Health Corp.The Clarius Ultrasound System is a portable ultrasound imaging device that wirelessly connects to smartphones or tablets, allowing medical professionals to perform real-time ultrasound scans for various clinical applications such as emergency triage, procedure guidance, fetal imaging, and musculoskeletal assessment. It supports multiple probes and is designed for use by trained healthcare providers in clinical settings.
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body for multiple clinical applications, including emergency triage, needle guidance, fetal, abdominal, musculoskeletal, cardiac, and vascular imaging by trained medical professionals.
Technology
A portable, software-controlled diagnostic ultrasound device with wireless transducers communicating via Wi-Fi to iOS or Android devices. Uses piezoelectric transducers for high-frequency, non-ionizing sound wave transmission and echo reception, with onboard battery, beam forming, and signal processing. Images are displayed on external smart devices for point-of-care use.
Performance
Non-clinical performance testing demonstrated compliance with IEC 60601-1 (2012), IEC 60601-1-2 (2014) for electromagnetic capability, IEC 60601-2-37 standards for ultrasonic diagnostic devices, and ISO 10993-1 for biological evaluation, supporting substantial equivalence and device safety.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/9/2016
21 days - 2
FDA Approval
11/30/2016
Other devices from Clarius Mobile Health Corp.
- Clarius OB AI2024 • 510K
- Clarius Bladder AI2023 • 510K
- Clarius Ultrasound Scanner2023 • 510K
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