FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

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.

FDA #
K232704
Product Code
IYN

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.

FDA #
K213436
Product Code
IYN

The Clarius Ultrasound Scanner is a portable, software-controlled ultrasound system that connects wirelessly to iOS or Android devices to provide high-resolution, real-time diagnostic ultrasound and Doppler imaging. It supports multiple clinical applications such as abdominal, cardiac, musculoskeletal, fetal, and procedural guidance, helping clinicians perform ultrasound imaging conveniently in diverse healthcare settings.

FDA #
K192107
Product Code
IYN

The Clarius Ultrasound Scanner is a portable, wireless ultrasound imaging system designed for diagnostic use across multiple body regions. It connects via Wi-Fi to mobile devices, allowing healthcare professionals to visualize real-time, high-resolution ultrasound images and fluid flow analysis in diverse clinical applications such as fetal, abdominal, cardiac, musculoskeletal, and more. This device facilitates medical imaging in varied clinical environments by enabling image acquisition on tablets and smartphones.

FDA #
K180799
Product Code
IYN

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.

FDA #
K172385
Product Code
IYN

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.

FDA #
K163138
Product Code
IYN
Page 1 of 16 results
1

Ready to Sharpen Your Edge?

Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.

We respect your privacy. Unsubscribe at any time.