Data / Medical devices / United States / Echonous, Inc.

Echonous, Inc.: FDA-registered device maker in Redmond, WA, United States, 7 510(k) clearances

Name: Echonous, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Echonous, Inc. is registered with the FDA (registration 3013757696) in Redmond, WA, United States. It lists 7 device types. The FDA files 7 510(k) clearances under its listings, the newest dated April 25, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013757696
Address: 8310 154th Ave NE Building B, Suite 200, Redmond, WA, United States, 98052
Owner or operator: ECHONOUS, INC. (10055454)
Roles: Complaint file establishment, Manufacturer, Remanufacturer
First device listed: July 26, 2017
Registered through: 2026
Brand names listed: AI Station 2, EchoNous Bladder, EchoNous System, EchoNous Vein, KOSMOS, Kosmos, Kosmos Binaural Headset, Kosmos Bridge and more

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Manufacturer	accessdata.fda.gov
Electrocardiograph	DPS	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
Stethoscope, Electronic	DQD	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
System, Digital Image Communications, Radiological	LMD	1	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 25, 2025	K242321	Kosmos	IYN	Substantially Equivalent	EchoNous, Inc.	accessdata.fda.gov
August 29, 2024	K233826	Kosmos	IYN	Substantially Equivalent	EchoNous, Inc.	accessdata.fda.gov
August 6, 2021	K212100	Kosmos	IYN	Substantially Equivalent	EchoNous, Inc.	accessdata.fda.gov
March 26, 2020	K193518	KOSMOS	IYN	Substantially Equivalent	EchoNous, Inc.	accessdata.fda.gov
July 10, 2018	K181574	Uscan	IYO	Substantially Equivalent	EchoNous, Inc.	accessdata.fda.gov
March 21, 2016	K160420	SpeqT	IYO	Substantially Equivalent	Signostics Limited	accessdata.fda.gov
May 7, 2009	K090505	SPEQ ULTRASOUND SYSTEM	IYO	Substantially Equivalent	Signostics Pty, Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 9, 2024	94709	Class II	Ongoing	Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.	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.	accessdata.fda.gov

Compare with other makers

Updated April 25, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.