# K193518: Kosmos

- Pathway: 510(k) (Traditional)
- Applicant: EchoNous, Inc.
- Decided: Mar 26, 2020 after 98 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
Longest line of descent: 21 generations back to K935595 (1995). 158 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 160 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180995: Vscan Extend, GE Medical Systems Ultrasound and Primary Care Diagnostics (2018) Summary page 4.
- K170874: Eko Model E5 System (EME5), Eko DUO, Eko Devices, Inc. (2017) Summary page 4.

## Most influential descendants
- K212100: Kosmos (2021), 0 descendants of its own

## Indications for use
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 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, M-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.

Source page: https://510kreport.com/device/K193518
Methodology: https://510kreport.com/methodology