Extracorporeal ultrasound imaging system transducer, hand-held

Intended purpose

Kosmos is a general-purpose diagnostic ultrasound system intended to be used by qualified and trained healthcare professionals in the clinical assessment of the cardiac and pulmonary systems and the abdomen by acquiring, processing, displaying, measuring, and storing ultrasound images. Kosmos is intended to be used in clinical care and medical education settings on adult and pediatric patient populations. Kosmos OTS consists of Kosmos Torso-One or Kosmos Lexsa connected by cable to a compatible off-the-shelf tablet which runs the Kosmos Ultrasound App. When the display is connected to a Kosmos probe, the combination is configured as a medical electrical system. The following probes are available for Kosmos OTS: • Kosmos Torso-One-USB: A phased array probe that supports non-invasive Cardiac, Thoracic/Lung and Abdominal imaging. • Kosmos Lexsa: A linear array probe that supports non-invasive Lung, Vascular/Peripheral Vascular, Musculoskeletal and interventional guidance (includes needle/catheter placement, fluid drainage, and nerve block). Modes of Operation for Kosmos on Android: B-mode, M-mode, Color Doppler, combined modes of B+M and B+CD, PW Doppler, CW Doppler, TDI, and Harmonic Imaging Modes of Operation for Kosmos on iOS: B-mode, M-mode, Color Doppler, combined modes of B+M and B+CD, and Harmonic Imaging The following probes are available for Kosmos on Bridge: • Kosmos Torso: A phased array transducer that combines ultrasound, ECG and digital auscultation in one probe. • Kosmos Torso-One: A phased array probe and supports non-invasive Cardiac, Thoracic/Lung and Abdominal imaging. • Kosmos Lexsa: A linear array ultrasound probe that supports non-invasive Lung, Vascular/Peripheral Vascular, Musculoskeletal and interventional guidance (includes needle/catheter placement, fluid drainage, and nerve block). Modes of Operation for Kosmos on Bridge: B-mode, M-mode, Color Doppler, Pulsed-Wave (PW) Doppler, Tissue Doppler Imaging (TDI), Continuous-Wave (CW) Doppler, Combined Modes of B+M, and B+CD, B+PW, B+CW, and Harmonic Imaging Clinical Applications: Cardiac, Thoracic/Lung, Abdominal, Vascular/Peripheral Vascular, Musculoskeletal, and interventional guidance (includes needle/catheter placement, fluid drainage, and nerve block) Modes of Operation: B-mode, M-mode, Color Doppler, Pulsed-Wave (PW) Doppler, Tissue Doppler Imaging (TDI), Continuous-Wave (CW) Doppler, Combined Modes of B+M, and B+CD, B+PW, B+CW, and Harmonic Imaging Kosmos is intended to be used in clinical care and medical education settings on adult and pediatric patient populations. The device is non-invasive, reusable, and intended to be used on one patient at a time.