# K233826: Kosmos

- Pathway: 510(k) (Traditional)
- Applicant: EchoNous, Inc.
- Decided: Aug 29, 2024 after 272 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K252558: Lumify Diagnostic Ultrasound System (2026), 0 descendants of its own

## Indications for use
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/Peripheral 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 pediatric patient populations. Kosmos includes the AI-assisted automated ejection fraction software, known as Auto EF, which is used to process previously acquired transthoracic cardiac ultrasound images, 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-time 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.

Source page: https://510kreport.com/device/K233826
Methodology: https://510kreport.com/methodology