Clarius Ultrasound Scanner
Clarius Mobile Health Corp.The Clarius Ultrasound Scanner is a portable, software-controlled ultrasound device that wirelessly connects to iOS or Android devices to provide real-time, high-resolution diagnostic ultrasound images across many clinical applications such as cardiac, abdominal, pediatric, and musculoskeletal imaging. It helps healthcare professionals by offering dual-array transducer functionality in a single device, enhancing convenience and efficiency during ultrasound exams.
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 multiple applications such as 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 is a portable, software-controlled diagnostic ultrasound device consisting of wireless transducers using Bluetooth and Wi-Fi to communicate with iOS or Android mobile devices. The PAL HD3 transducer integrates dual array designs (high-frequency linear and low-frequency phased arrays) side-by-side within one scanner, allowing selection between arrays without changing devices. Modes include B-mode, M-mode, Color Doppler, Power Doppler, and Pulse-Wave Doppler.
Performance
Performance and safety were demonstrated via non-clinical testing including compliance with IEC and ISO standards for medical device software, electrical safety, electromagnetic compatibility, usability, biocompatibility, and acoustic output. Clinical studies were not required to support substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/5/2023
1 month - 2
FDA Approval
10/5/2023
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