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Kosmos

by EchoNous, Inc. 4 variants

510(k) K193518

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K193518↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK193518 Date26 Mar 2020ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K193518 decided 26 Mar 2020 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
IYN
Device class
Class II
Regulation
21 CFR Part 892.1550
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

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

Cited by

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 Point-of-Care Ultrasound (POCUS) device designed for real-time diagnostic imaging at the bedside. It integrates artificial intelligence to enhance image acquisition, analysis, and interpretation, supporting clinical decision-making in radiology applications. The device combines cart-based imaging quality with handheld portability, enabling flexible use across diverse clinical settings. Its AI capabilities assist in guiding probe positioning and optimizing image clarity for improved diagnostic confidence.

Kosmos is supplied as a reusable medical device, intended for use in MRI-safe environments (as per manufacturer specifications). It is regulated under FDA 510(k) clearance (K193518) and MDR compliance, with a product code classification of IYN under the Radiology advisory committee. The device requires proper storage and maintenance per manufacturer guidelines to ensure performance integrity, though specific sterility or single-use details are not provided in the data.

Devices cleared under K193518

24 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 K193518
UDI-DISize and differences
AI Station 2 P006200
EchoNous
P00620009353278000229
Prescription: no
On the market
Binaural Headset - Refurbished R006115
EchoNous
R00611509353278000489
Prescription: yes
On the market
Kosmos Accessories - International P006105
EchoNous
P00610509353278000250
Prescription: yes
On the market
Kosmos Accessories - US - Refurbished R006208
EchoNous
R00620809353278000465
Prescription: yes
On the market
Kosmos Accessories - US P006208
EchoNous
P00620809353278000267
Prescription: yes
On the market
Kosmos Binaural Headset P006115
EchoNous
P00611509353278000212
Prescription: yes
On the market
Kosmos Bridge - Refurbished R006030
EchoNous
R00603009353278000458
Prescription: yes
On the market
Kosmos Bridge P006030
EchoNous
P00603009353278000120
Prescription: yes
On the market
Kosmos ECG Patient Cable - International P006186
EchoNous
P00618609353278000243
Prescription: yes
On the market
Kosmos ECG Patient Cable - US P005779
EchoNous
P00577909353278000144
Prescription: yes
On the market
Kosmos Lexsa (Refurbished) R006709
EchoNous
R00670909353278000625
Prescription: yes
On the market
Kosmos Lexsa P006709
EchoNous
P00670909353278000519
Prescription: yes
On the market
Kosmos OTS Android Doppler Software Package P007701
EchoNous
P00770109353278000700
Prescription: yes
On the market
Kosmos OTS Android Linear Color P007465
EchoNous
P00746509353278000694
Prescription: yes
On the market
Kosmos OTS Android Linear P007213
EchoNous
P00721309353278000687
Prescription: yes
On the market
Kosmos OTS iOS P007944
EchoNous
P00794409353278000762
Prescription: yes
On the market
Kosmos OTS iOS Software Package P007639
EchoNous
P00763909353278000717
Prescription: yes
On the market
Kosmos OTS P006576
EchoNous
P00657609353278000588
Prescription: yes
On the market
Kosmos Torso - Refurbished R006025
EchoNous
R00602509353278000441
Prescription: yes
On the market
Kosmos Torso P006025
EchoNous
P00602509353278000137
Prescription: yes
On the market
Kosmos Torso-One - Refurbished R006440
EchoNous
R00644009353278000434
Prescription: yes
On the market
Kosmos Torso-One - USB P006632
EchoNous
P00663209353278000502
Prescription: yes
On the market
Kosmos Torso-One - USB R006632
EchoNous
R00663209353278000571
Prescription: yes
On the market
Kosmos Torso-One P006440
EchoNous
P00644009353278000410
Prescription: yes
On the market

Similar devices

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

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