Clarius Ultrasound Scanner
Clarius Mobile Health Corp.The Clarius Ultrasound Scanner is a portable, software-controlled ultrasound system that wirelessly connects to smartphones or tablets to provide high-resolution, real-time diagnostic ultrasound images. It supports a wide range of clinical applications including cardiac, musculoskeletal, abdominal, fetal, and procedural guidance, helping healthcare professionals diagnose and monitor patients with ease and mobility.
Intended Use
The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in ophthalmic, fetal, abdominal, intra-operative (non-neurological), pediatric, small organ, cephalic (adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, gynecology, cardiac (adult, pediatric), peripheral vessel, carotid, and procedural guidance of needles into the body.
Technology
The system uses wireless transducers with Bluetooth and Wi-Fi to communicate with iOS or Android devices. It acquires high-frequency, non-ionizing ultrasound waves with piezoelectric transducers to generate diagnostic images. The product includes multiple transducer types (convex, linear, phased, intracavity) and software (Clarius App) for image display. It is portable, battery powered, and intended for use by trained healthcare professionals.
Performance
Non-clinical performance testing and validation were conducted to demonstrate safety and effectiveness, showing compliance with multiple international safety and performance standards for medical electrical equipment and ultrasound devices. Testing included IEC 60601 series, ISO 10993-1, IEC 62304 software lifecycle, IEC 62366 usability, and others. The device showed substantial equivalence to the predicate device with no new safety or effectiveness concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/22/2021
24 days - 2
FDA Approval
11/15/2021
Other devices from Clarius Mobile Health Corp.
- Clarius OB AI2024 • 510K
- Clarius Bladder AI2023 • 510K
- Clarius Ultrasound Scanner2023 • 510K
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