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Exo Iris is indicated for use by qualified and trained healthcare professionals in environments where healthcare is provided to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients for the following clinical applications: Peripheral Vessel (including carotid, deep vein thrombosis and arterial studies), Procedural Guidance, Small Organ (including thyroid, scrotum and breast), Cardiac, Abdominal, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial) and Ophthalmic. Modes of operation include: B-Mode + Color Doppler, B-Mode + M-Mode.

The subject device, Exo Iris is a hand-held, general purpose diagnostic imaging system used to enable visualization of anatomical structures and fluid of adult and pediatric patients. The system is intended to be used by trained healthcare professionals. The system generates 2D images using a single ultrasound transducer with broad imaqing capabilities. The imaqes are displayed on a commercial off-the-shelf mobile device (iPhone) by means of a proprietary mobile application (Exo Iris app) provided by Exo Imaging. Images can be displayed in the following modes: B-Mode, B-Mode + Color Doppler, B-Mode+ M-Mode. The mobile application's user interface includes touchscreen menus, buttons, controls, indicators, and navigation icons that allow the operator to control the system and to view ultrasound images.

Exo Iris is indicated for use by qualified and trained healthcare professionals in environments where healthcare is provided to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients for the following clinical applications: Peripheral Vessel (including carotid, deep vein thrombosis and arterial studies), Small Organ (including thyroid, scrotum and breast), Cardiac, Abdominal, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial). Modes of operation include: B-mode, B-mode + Color Doppler.

Exo Iris is a hand-held, general purpose diagnostic imaging system used to enable visualization of anatomical structures and fluid of adult and pediatric patients. The system is intended to be used by trained healthcare professionals. The system generates 2D images using a single ultrasound transducer with broad imaging capabilities. The images are displayed on a commercial off-the-shelf mobile device (iPhone) by means of a proprietary mobile application (Exo Iris app) provided by Exo Imaging. Images can be displayed in the following modes: B-Mode, B-Mode + Color Doppler. The mobile application's user interface includes touchscreen menus, buttons, controls, indicators, and navigation icons that allow the operator to control the system and to view ultrasound images.