Kosmos Ultrasound Imaging System by EchoNous

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Traditional	NumberK212100	Date6 Aug 2021Cleared	StatusActive
European Union	CE/MDR EUDAMED	Number—	Date—	StatusActive

Official records

EUDAMED public site
FDA 510(k) database 510(k) number K212100

Across registries

2 registries list this device

FDA 510(k) K212100 decided 6 Aug 2021 Active
EUDAMED Active

Recalls

1 recall · 1 ongoing · FDA

- Ongoing Z-2325-2024 FDA Class II initiated 9 May 2024
Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd party software, such as PACS or other post-processing software, which may lead to inaccurate diagnoses or treatment.

Timeline

2 dated events

6 Aug 2021 Cleared FDA 510(k) K212100
9 May 2024 Recall initiated FDA recalls Z-2325-2024

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number: K212100
FDA product code: IYN

Device class: Class II
Regulation: 21 CFR Part 892.1550
Advisory committee: Radiology
FDA decision: SESE Substantially Equivalent

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Kosmos K193518 26 Mar 2020 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Kosmos is a diagnostic ultrasound imaging system, designed for real-time visualization of internal body structures using high-frequency sound waves. It is classified under the product code IYN (Ultrasound Imaging Systems) and is intended for radiologic examination and diagnostic purposes in clinical settings.

This device is supplied as a reusable medical instrument, requiring appropriate sterilization and maintenance protocols to ensure safety and functionality. It is authorized under FDA 510K clearance (K212100) and meets MDR compliance standards. The system is intended for use in radiology departments and clinical environments where ultrasound imaging is performed, adhering to standard operating procedures for medical imaging equipment.

Devices cleared under K212100

14 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K212100
		UDI-DI	Size and differences
Kosmos Hub (Refurbished) R006966 EchoNous	R006966	09353278000618	—	On the market
Kosmos Hub P006966 EchoNous	P006966	09353278000595	—	On the market
Kosmos Lexsa (Refurbished) R006709 EchoNous	R006709	09353278000625	—	On the market
Kosmos Lexsa P006709 EchoNous	P006709	09353278000519	—	On the market
Kosmos OTS Android Doppler Software Package P007701 EchoNous	P007701	09353278000700	—	On the market
Kosmos OTS Android Linear Color P007465 EchoNous	P007465	09353278000694	—	On the market
Kosmos OTS Android Linear P007213 EchoNous	P007213	09353278000687	—	On the market
Kosmos OTS iOS P007944 EchoNous	P007944	09353278000762	—	On the market
Kosmos OTS iOS Software Package P007639 EchoNous	P007639	09353278000717	—	On the market
Kosmos OTS P006576 EchoNous	P006576	09353278000588	—	On the market
Kosmos P008041 EchoNous	P008041	09353278000847	—	On the market
Kosmos P008042 EchoNous	P008042	09353278000830	—	On the market
Kosmos Power Pack (Refurbished) R007640 EchoNous	R007640	09353278000724	—	On the market
Kosmos Power Pack P007640 EchoNous	P007640	09353278000632	—	On the market

Similar devices

Other devices filed under FDA product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

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