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Kosmos is 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. With respect to its ultrasound imaging capabilities, Kosmos is a general purpose diagnostic ultrasound system used in the following clinical applications and modes of operation: Clinical Applications and Modes of Operation for Kosmos on Android - Clinical applications: - Torso-One: Cardiac, Thoracic/Lung, Abdominal, and Obstetrics/Gynecology. - Lexsa: Lung, Vascular/Peripheral Vascular, Musculoskeletal, Nerve and image Guidance for Needle/Catheter Placement (includes needle/catheter placement, fluid drainage, and nerve block) - Modes of operation: B-mode, M-mode, Color Doppler, Color Power Doppler, combined modes of B+M and B+CD, PW Doppler, CW Doppler, TDI, 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.

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Kosmos is intended to be used by qualified and trained healthcare professionals in the clinical assessment for the following clinical applications by acquiring, processing, displaying, measuring, and storing ultrasound images, or synchronized ultrasound images, electrocardiogram (ECG) rhythms, and digital auscultation (DA) sounds and waveforms. With respect to its ultrasound imaging capability, Kosmos is a general-purpose diagnostic ultrasound system used in the following clinical applications and modes of operation: Clinical Applications: Cardiac, Thoracic/Lung, Abdominal, Vascular, Musculoskeletal, and interventional guidance (includes free hand needle / catheter placement fluid drainage, and nerve block) Modes of Operation: B-mode, M-mode, Color Doppler, Pulsed Wave (PW) Doppler, 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 pediations. Kosmos includes the Al-assisted automated ejection fraction software, known as Auto EF, which is used to process previously acquired transthoracic cardiac ultrages, to store images, and to manipulate and make measurements on images using the Kosmos. Auto EF provides automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation. Auto EF is indicated for use on adult patients only in healthcare facilities. The Kosmos includes the Auto Anatomical Structure Labeling and View Identification, also referred to as AI FAST, software, which is intended for use only by qualified and trained medical professionals for automatic real-lime detection and labeling of anatomical structures during image acquisition during cardiac, thoracic/lung, or abdominal ultrasound imaging. This feature is only indicated for use on adult patients in healthcare facilities. The device is non-invasive, reusable, and intended to be used on one patient at a time.

Kosmos is a general-purpose diagnostic ultrasound system used in the following clinical applications and modes of operation: Clinical Applications: Cardiac, Thoracic/Lung, Abdominal, Vascular, Musculoskeletal, and interventional guidance (includes free hand needle / catheter placement fluid drainage, and nerve block) Modes of Operation: B-mode, M-mode, Color Doppler, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Combined Modes of B+M, and B+CD, B+PW, B+CW, and Harmonic Imaging. Kosmos also includes Al-assisted automated ejection fraction software (Auto EF) and Auto Anatomical Structure Labeling and View Identification software (AI FAST).

Kosmos is intended to be used by qualified and trained healthcare professionals in the clinical assessment for the following clinical applications by acquiring, processing, displaying, measuring, and storing ultrasound images, or synchronized ultrasound images, electrocardiogram (ECG) rhythms, and digital auscultation (DA) sounds and waveforms. With respect to its ultrasound imaging capabilities, Kosmos is a general purpose diagnostic ultrasound system used in the following clinical applications and modes of operation: · Clinical Applications: Cardiac, Thoracic/Lung, Abdominal, Vascular, Musculoskeletal, and interventional guidance (includes needle/catheter placement, fluid drainage, and nerve block) · Modes of Operation: B-mode, Color Doppler, Pulsed-Wave (PW) Doppler, 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 pediations. The device is non-invasive, reusable, and intended to be used on one patient at a time.

Kosmos consists of a tablet (i.e., Kosmos Bridge or supported Off-The-Shelf Android tablet provided by the user) and probe (i.e., Kosmos Torso, Torso-One, or Lexsa), which connects to the tablet via a cable. Additional components include the ECG Patient Cable and Binaural Headset for use with Kosmos Torso only. Kosmos can operate on battery or while connected to mains, when used as either handheld device or mounted to the mobile stand (i.e., AI Station 2). The probe face houses an ultrasound transducer and sealed microphones for auscultation (Kosmos Torso only). The tablet (i.e., Kosmos Bridge or supported Off-The-Shelf Android tablet provided by the customer) displays clinical and patient data information including the display of ultrasound images, auscultation and ECG waveforms (when connected to Kosmos Torso), and patient data/reports. The tablet also includes speakers for sounds associated with system control and feedback. Additionally, the tablet offers a means of user control with its touchscreen display and buttons. Although its intended operation is not dependent on Wi-Fi, Kosmos supports Wi-Fi connectivity for: - patient data archival, - updating the embedded Kosmos Software (Kosmos Bridge configurations only), or ● - downloading or updating the Kosmos Software Application from the Google Play Store ● (Kosmos On Android configuration only) Kosmos' ECG capability provides a timing reference with respect to the cardiac cycle as compared with both ultrasound imaging and digital auscultation. Ultrasound imaging, ECG, and DA are all integrated into Kosmos Torso in a time-synchronized manner. Kosmos' 3-lead single-channel ECG allows for the acquisition and display of a single ECG waveform (lead), which can be any one of the Lead I, or Lead III waveforms. One end of Kosmos' ECG cable connects to the probe via a custom-designed magnetic connector. The other end has three (3) RA/LA/LL leadwires to be connected to user-supplied clip-style electrodes affixed to the patient using the standard RA/LA/LL configuration. Kosmos is an FDA-cleared medical device: however, the new AI-assisted EF Workflow and Trio tool are not yet cleared by the FDA. Instead, EchoNous is following the Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, Guidance for Industry and Food and Drug Administration Staff, April 2020 for this new feature.

KOSMOS is 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, displaying, measuring, and storing synchronized ultrasound images, electrocardiogram (ECG) rhythms, and digital auscultation (DA) sounds and waveforms. With respect to its ultrasound imaging capabilities, KOSMOS is a general purpose diagnostic ultrasound system used in the following clinical applications and modes of operation: - . Clinical Applications: Cardiac, Thoracic/Lung, Abdominal, Peripheral Vascular, and Image Guidance for Needle/Catheter Placement - . Modes of Operation: B-mode, Color Doppler, Combined Modes of B+M and B+CD, 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.

KOSMOS consists of a tablet and probe, which connects to the tablet via a cable. Its accessories include a power charger, ECG cable, and binaural headset. KOSMOS can operate on battery or while connected to mains. The probe face houses an ultrasound transducer and sealed microphones for auscultation. The tablet can display clinical and patient data information including the display of ultrasound images, auscultation and ECG waveforms, and patient data/reports. The tablet also includes speakers for sounds associated with system control and feedback. Additionally, the tablet offers a means of user control with its touchscreen display and buttons. Although its intended operation is not dependent on Wi-Fi, KOSMOS supports Wi-Fi connectivity for patient data archival. The tablet can be positioned on a flat surface close to the patient while the user holds the probe with one hand to scan the patient. The user's other hand is then free to interact with the tablet using its touchscreen and buttons. The user can also hold the tablet in one hand and the probe in the other hand to scan the patient. KOSMOS' ECG capability provides a timing reference with respect to the cardiac cycle as compared with both ultrasound imaging and digital auscultation. Ultrasound imaging, ECG, and DA are all integrated into the probe in a time-synchronized manner. KOSMOS' 3-lead single-channel ECG allows for the acquisition and display of a single ECG waveform (lead), which can be any one of the Lead II, or Lead III waveforms. One end of the ECG cable connects to the probe via a custom-designed magnetic connector. The other end has three (3) RA/LA/LL leadwires to be connected to usersupplied clip-style electrodes affixed to the patient using the standard RA/LA/LL configuration.

The Uscan is for non-invasive imaging of the human body and is intended for the following applications: Abdominal. Musculoskeletal, Pediatric, Small Organ, and Peripheral Vessel. Users must have ultrasound training for abdominal, musculoskeletal, pediatric, small organ, and peripheral vessel imaging. The Uscan can also be used to obtain an image of the bladder that is used to automatically determine bladder volume.

The Uscan is a hand-held, diagnostic ultrasound system with an on-screen display. Its purpose is to acquire ultrasound echo data and display it in B-Mode on an off-the-shelf display. Automated bladder volume measurements are supported.