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The Imagio Ultrasound Imaging System is intended for the following applications: Abdominal, Small Parts, Musculoskeletal conventional, and Musculoskeletal superficial. The system also provides the ability to measure anatomical structures {abdominal, small organ, and musculo-skeletal} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Imagio Ultrasound Imaging System is a multi-purpose mobile, software controlled diagnostic ultrasound system with on-screen thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic imaging on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console. The systems provide measurement capabilities for anatomical structures that provide information used for clinical diagnostic purposes. The system has a PW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage. The system is designed for use in linear scanning modes, and supports linear array probes. The Imagio Ultrasound Imaging System is comprised of the following subsystems provided by Analogic Corporation, (previously Ultrasonix), and used in common with the predicate device: - Modulo - ultrasound acquisition subsystem: - ultrasound transmit and receive electronics; - transducer interface connection to transducer accessory; - computer control, image formation, and image processing; - control console; - clinical display; - L14-5/38 transducer; - ultrasound imaging software; The above subsystems from the predicate device are incorporated in the Imagio Ultrasound Imaging System together with the following Seno Medical designed components: Cart Mechanical Design - frame; - casters; - wheel locking; - adjustable height mounting arm for console and display; - cart electrical; - electrical wiring and optical cables; - power distribution unit; - enclosures; - USB alpha-numeric keyboard assembly. Note that the Analogic software has been modified to remove support for applications and transducers not needed by Seno Medical customers.