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The Dolphin Medical Imaging USB Ultrasound System is intended for diagnostic ultrasound imaging in B mode. It is indicated for diagnostic ultrasound imaging in the following applications: - · Fetal/Obstetric - Abdominal Pediatric - · Small Organ - · Musculo-skeletal (conventional) - · Musculo-skeletal (superficial) - · Urology - · Gynecology - · Pelvic Floor - · Neuro-muscular - · Peripheral Vessel The system is intended for use by trained registered nurses and other trained healthcare professional healthcare environment.

The Dolphin Medical Imaging Ultrasound System ("DMI US") is a self-contained, solid-state portable ultrasound imaging system, physically comprised of the FDA-cleared Interson SP-L01 USB ultrasound probe (K163443), which is used in connection with the DMI US application software. The system contains an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface, B-mode imaging and application software providing the user interface. The DMI US application software provides a task-oriented graphical user interface that runs on a personal computer with a USB 2.0 (or greater) port and the Windows 10 operating system. The user-selectable tasks supported are peripheral intravenous access and central venous access. The software application displays the ultrasound B-mode image at a depth appropriate for the selected task. The initial operational settings of the probe and/or application are preprogrammed in the system. User-customized parameter settings for each probe and/or application may be set by the operator and stored for recall as needed via the software user interface. Customization includes changing image brightness (gain), changing depth and freezing/unfreezing the ultrasound image. The system uses a probe with solid-state ultrasound array transducers which provide high resolution, high penetration performance