FDA Radiology AI Devices

The Readius series (L15, P8, V6, C6) are digital color Doppler ultrasound imaging systems designed for diagnostic use by qualified physicians. They support various scanning modes to image abdominal areas, small organs like the thyroid and breast, and peripheral vascular structures. The systems enable B-mode, M-mode and advanced Doppler flow imaging to assist clinicians in evaluating blood flow and tissue characteristics in real time.

The Resona A10S and related series are advanced diagnostic ultrasound systems used by healthcare professionals to acquire, display, and analyze ultrasound images and measurements of the human body. The system supports a wide range of ultrasound imaging modes and can be used in diverse clinical applications such as cardiac, abdominal, gynecologic, and musculoskeletal exams, thus aiding clinicians in diagnosis and patient care.

The Versana Premier, Versana Premier Lotus, and LOGIQ F are diagnostic ultrasound systems intended for use by trained healthcare professionals. They provide ultrasound imaging, measurement, display, and analysis for various body regions and clinical applications including fetal, abdominal, cardiac, vascular, musculoskeletal, and more, helping clinicians visualize and diagnose conditions through advanced ultrasound technology.

The Butterfly iQ3 Ultrasound System is a portable, hand-held ultrasound device used by trained healthcare professionals to capture diagnostic ultrasound images and measurements across multiple clinical areas such as cardiac, abdominal, lung, musculoskeletal, fetal/obstetric, and more. It offers various imaging modes and supports professional use in diverse healthcare environments, helping clinicians visualize anatomical structures and fluids for adult and pediatric patients.

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.

The EPIQ Series Diagnostic Ultrasound System by Philips Ultrasound LLC is a diagnostic ultrasound imaging device used to visualize and analyze fluid flow in the human body. It supports a wide range of clinical applications including abdominal, cardiac, vascular, musculoskeletal, and ophthalmic imaging, enhancing clinicians' ability to diagnose and guide treatment with high-resolution imaging and fluid flow analysis.

Ultrasound System 2300 is a mobile, software-controlled diagnostic ultrasound system designed for a wide range of clinical applications including fetal, abdominal, pediatric, neuro, cardiac, and musculoskeletal imaging among others. It supports multiple ultrasound modes such as B-Mode, Doppler, Elastography, and Contrast Imaging to assist qualified healthcare professionals in imaging and guiding puncture and biopsy procedures, thereby improving diagnostic confidence and procedural accuracy.

The Voluson P6 and Voluson P8 are general-purpose diagnostic ultrasound systems designed for use by trained healthcare professionals. These systems support a variety of clinical applications, including fetal/obstetrics, abdominal, cardiac, pediatric, vascular, musculoskeletal, and small organ imaging. They provide high-quality real-time imaging, including 3D/4D modes, and Doppler imaging types, aiding clinicians in the diagnosis and monitoring of patients in hospital or clinical settings.

The Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 by Canon Medical Systems Corporation, is a high-quality diagnostic ultrasound system that provides detailed visualization of structures and dynamic processes in the human body. It supports multiple ultrasound modes and is suitable for use in hospitals and clinical settings, aiding clinicians in diagnosing conditions across areas including fetal, abdominal, cardiac, musculoskeletal, vascular, breast, and more.

The Voluson S Series (including S6, S8, S8t, S10, and S10 Expert) by GE Healthcare is a general-purpose diagnostic ultrasound system designed for use by trained healthcare professionals. It provides high-performance ultrasound imaging and analysis with a focus on real-time 3D/4D acquisition across multiple clinical applications such as obstetrics, abdominal, cardiac, vascular, and musculoskeletal imaging. The system supports a variety of probes and modes including Doppler imaging, elastography, and contrast imaging, helping clinicians visualize and measure various body tissues and fluids in a hospital or clinical setting.