Clarius Ultrasound System

The Clarius Ultrasound System is a portable diagnostic tool that employs wireless, software-controlled piezoelectric transducers (C3 convex and L7 linear) to transmit real-time ultrasound images to standard iOS or Android devices. It is designed to provide an accessible, high-performance, low-cost platform for point-of-care imaging and procedural guidance across a wide range of clinical applications for trained medical professionals.

The Clarius Ultrasound System is a portable, general-purpose, software-controlled diagnostic tool designed for acquiring and displaying high-resolution, real-time ultrasound data. It utilizes wireless transducers, specifically the Clarius Scanner C3 (convex) and Clarius Scanner L7 (linear), which communicate via Wi-Fi Direct with commercial off-the-shelf (COTS) iOS or Android devices running the Clarius App. The system's primary purpose is to facilitate point-of-care imaging, including emergency triage exams for trauma, guidance for needle and catheter placement, nerve block procedures, and various targeted diagnostic and measurement applications across fetal, fetal echo, abdominal, small organ, musculoskeletal (conventional and superficial), urological, gynecological, cardiac (adult and pediatric), peripheral vascular, pediatric, and carotid imaging. It is intended for use by trained medical professionals in professional healthcare facilities. The underlying science of the Clarius Ultrasound System involves piezoelectric material within its transducers, which transmit high-frequency, non-ionizing sound waves into the body and convert the returning echoes into electronic signals to construct anatomical images. Each wireless transducer is self-contained, housing a removable battery, power generator, multichannel beam former, pre-scan converter, and Wi-Fi components. The system package includes the Clarius App, a choice of transducer, a battery pack, a battery charger, an OEM medical power supply, and ultrasound transmission gel. The device is designed as an easy-to-use, high-performance, low-cost ultrasound platform for teaching and clinical applications, though it is not intended for use in emergency medical services, ambulances, or aircraft, nor for ophthalmic, intra-operative (e.g., introducing a scanner into a surgical incision or burr hole), endocavitary (e.g., introducing a scanner within a body cavity or organ), or open wound applications.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What is the typical battery life of the wireless transducers (C3 and L7 models) during continuous scanning, and what is the recharge time for the removable battery pack?; How does the image resolution and penetration depth of the Clarius C3 and L7 scanners compare to predicate portable ultrasound devices, particularly in diverse patient populations and for specific indicated uses like fetal echo or deep abdominal imaging?; What are the specific data encryption and security protocols employed during the Wi-Fi Direct transmission of ultrasound images and patient data to COTS iOS/Android devices to ensure appropriate data protection standards?; What is the recommended learning curve or minimum training requirement for clinicians to achieve proficiency in using the Clarius Ultrasound System for both diagnostic imaging and its various procedure guidance applications?; Are there any known interferences or performance limitations when operating the Clarius Ultrasound System in environments with multiple Wi-Fi networks or other wireless medical devices?