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

Sonavex, Inc.: FDA-registered device maker in Baltimore, MD, United States, 3 510(k) clearances

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

Sonavex, Inc. is registered with the FDA (registration 3014680735) in Baltimore, MD, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 23, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3014680735
Address: 2835 Odonnell ST Ste 200, Baltimore, MD, United States, 21224
Owner or operator: Sonavex, Inc. (10057900)
Roles: Manufacturer
First device listed: June 11, 2018
Registered through: 2027
Brand names listed: EchoGuide, EchoMap, EchoMark, EchoMark LP, EchoSure

Devices it lists

Device	Product code	Class	Role	Source
Marker, Radiographic, Implantable	NEU	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Manufacturer	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 23, 2025	K243479	EchoGuide (Version 1)	IYO	Substantially Equivalent	Sonavex, Inc.	accessdata.fda.gov
March 8, 2019	K190039	EchoSure Diagnostic Ultrasound System	IYO	Substantially Equivalent	Sonavex, Inc.	accessdata.fda.gov
June 6, 2018	K180621	EchoMark, EchoMark LP	NEU	Substantially Equivalent	Sonavex, Inc.	accessdata.fda.gov

Compare with other makers

Updated April 23, 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.