Clarius Ultrasound System
Clarius Mobile Health Corp.The Clarius Ultrasound Scanner is a portable, software-controlled ultrasound system designed for diagnostic imaging and fluid flow analysis across a broad range of clinical applications including ophthalmic, fetal, abdominal, cardiac, musculoskeletal, and more. It wirelessly connects to iOS or Android devices, enabling clinicians to acquire high-resolution real-time ultrasound images and Doppler flow data for enhanced diagnostic evaluation and procedural guidance.
Intended Use
Diagnostic ultrasound imaging and fluid flow analysis in ophthalmic, fetal, abdominal, intra-operative (non-neurological), pediatric, small organ, cephalic (adult), musculo-skeletal, urology, gynecology, cardiac (adult and pediatric), fetal echo, peripheral vessel, carotid, and procedural guidance of needles.
Technology
Portable wireless diagnostic ultrasound system with software app control on iOS/Android devices. Uses piezoelectric transducers with beamforming and Wi-Fi Direct communication, capable of real-time high-resolution imaging using B-mode, M-mode, Color Doppler, Power Doppler, and combined modes. Includes multiple transducer options (convex, linear) and optional clip-on accessory for linear transducer functionality.
Performance
Nonclinical performance testing demonstrates compliance with numerous IEC and ISO standards for electrical safety, electromagnetic compatibility, usability, biological safety, software lifecycle, and acoustic output. No clinical testing was required to establish substantial equivalence. Quality assurance processes included risk analysis, verification and validation, and design reviews.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/8/2017
1 month - 2
FDA Approval
9/14/2017
Other devices from Clarius Mobile Health Corp.
- Clarius OB AI2024 • 510K
- Clarius Bladder AI2023 • 510K
- Clarius Ultrasound Scanner2023 • 510K
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