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The iQ3 Ultrasound System is indicated for use by qualified and trained healthcare professionals 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 Organs (including thyroid, scrotum and breast), Cardiac, Abdominal, Lung, Procedural Guidance, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial) and Ophthalmic. Modes of operation include B-mode + M-mode, B-mode + Color Doppler, B-mode + Power Doppler, Spectral Pulsed Wave Doppler, Fetal Heart Sounds, B-mode + Biplane, B-mode + Needle Viz Tool, B-mode + Biplane + Needle Viz Tool, B-mode + Multi-Slice, and B-mode + Sweep. The Butterfly iQ3 Ultrasound System's portability and user interface enables integration into professional healthcare facilities (e.g. Hospital, clinic. hospice, or medical office), home healthcare environment, ambulances and/or accident sites, and other environments where healthcare is provided. Users may also include medical students working under the supervision or authority of a physician during their education/training.

The Butterfly iQ3 Ultrasound System is a portable, hand-held, general-purpose diagnostic imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid on adult and pediatric patients. The system consists of a single transducer with broad imaging capabilities connected via a USB cable to a standard handheld commercial off the shelf (COTS) mobile device. In addition to M-mode and B-mode imaging the instrument also supports Color Flow Doppler imaging. The user interface includes touch screen menus, buttons, controls, indication icons that allow the operator to control the system and to view and measure ultrasound imagerv.

The Butterfly iQ+ Ultrasound System is indicated for use by 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 ven thrombosis and arterial studies), Procedural Guidance, Small Organs (including thyroid, scrotum and breast), Cardiac, Abdominal, Lung, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial) and Ophthalmic. Modes of operation include B-mode + M-mode, B-mode + Color Doppler, B-mode + Power Doppler, Spectral Pulsed Wave Doppler.

The Butterfly iQ/Butterfly iQ+ Ultrasound System is a hand-held general-purpose diagnostic imaging system for use by trained healthcare professionals in environments where healthcare is provided to enable visualization and measurement of anatomical structures and fluid of adult and pediatric patients. The system consists of a single transducer with broad imaging capabilities connected to a standard handheld commercial off the shelf (COTS) mobile device compatible with the Butterfly iO/iO+ mobile application (app). The subject device introduces the Auto B-line Counter, a software application backed by an image analysis algorithm. The purpose of the Auto B-line Counter is to provide automated detection and automatic calculation of the number of B-lines to a user in a given rib space and also provides the users the capabilities of reviewing the detected B-lines (via visual overlays). The overlay of B-lines does not mark images for detection of specific pathologies. The Auto B-line Counter enables the automated identification and count of B-lines during a lung scan and is integrated into the existing Butterfly iQ/iQ+ mobile application for use with the Butterfly iQ or iQ+ transducers.

The Butterfly iQ Ultrasound System is indicated for use by 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 Organs (including thyroid, scrotum and breast), Cardiac, Abdominal, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial) and Ophthalmic. Modes of operation include B- mode + M-mode, B-mode + Color Doppler, B-mode + Power Doppler.

The Butterfly iQ Ultrasound System is a general-purpose diagnostic imaging system for use by qualified and trained healthcare professionals in environments where healthcare is provided to enable visualization and measurement of anatomical structures and fluid of adult and pediatric patients. The system consists of a single transducer with broad imaging capabilities connected to a standard handheld commercial off the shelf (COTS) mobile device. In addition to M-mode imaging the instrument also supports Color Doppler and Power Doppler imaging. The user interface includes touchscreen menus, buttons, controls, indicators and navigation icons that allow the operator to control the system and to view and measure ultrasound imagery.

The Butterfly Auto 3D Bladder Volume Tool is a software application package. It is designed to view, quantify and report results acquired on Butterfly Network ultrasound systems for noninvasive volume measurements of the bladder, to support physician diagnosis. Indicated for use in adult populations.

The Butterfly Auto 3D Bladder Volume Tool is a software application used on Butterfly iQ Ultrasound Systems to provide a non-invasive measurement of bladder volume. The system calculates the bladder volume using proprietary artificial intelligence automatic segmentation and volume measurement algorithms on Butterfly Network ultrasound systems. The Auto 3D Bladder Volume Tool allows the clinician to calculate bladder volume when using the Bladder preset in B-mode. The tool is used to acquire 25, 2D images of the bladder. Once acquired, a volume estimate is calculated and presented back to the clinician. The clinician can then exit, restart the tool or save the acquisition to the study roll. The information presented is intended as additional input to standard diagnostic pathways and is only to be used by qualified clinicians. The Auto 3D Bladder Volume Tool is based on the image segmentation method, U-Net', and the volume calculation is computed using the process of integration over binary images.

The Poseidon Ultrasound System is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediativ for the following clinical applications: Peripheral Vessel (including carotid and arterial studies), Procedural Guidance, Small Organs (including thyroid), Cardiac, Abdominal, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional) and Musculoskeletal (superficial).

The Poseidon Ultrasound System is a general-purpose diagnostic imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid on adult and pediatric patients. The system consists of a single transducer with broad imaging capabilities connected via a USB cable to a standard handheld commercial off the shelf (COTS) mobile device. In addition to M-mode and B-mode imaging the instrument also supports Color Flow Doppler imaging. The user interface includes touchscreen menus, buttons, controls, indicators and navigation icons that allow the operator to control the system and to view and measure ultrasound imagery.