Data / Medical devices / United States / IMACOR, Inc

IMACOR, Inc: FDA-registered device maker in Jericho, NY, United States, 3 510(k) clearances

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

IMACOR, Inc is registered with the FDA (registration 3006382185) in Jericho, NY, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 8, 2022. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006382185
Address: 50 Jericho Turnpike Suite 105, Jericho, NY, United States, 11753
Owner or operator: ImaCor Inc (10023490)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: June 26, 2008
Registered through: 2026
Brand names listed: ClariTEE probe, ImaCor Zura Handheld, ImaCor Zura Inaging System, ImaCor Zura TEE system, Zura, Zura system

Devices it lists

Device	Product code	Class	Role	Source
Echocardiograph	DXK	2	Manufacturer, Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Complaint file establishment, Manufacturer, Specification developer	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 8, 2022	K220490	ImaCor Zura Handheld ZHH-010	IYN	Substantially Equivalent	Imacor, Inc.	accessdata.fda.gov
June 25, 2010	K100989	ZURA TEE SYSTEM WITH CLARITEE PROBE	IYN	Substantially Equivalent	Imacor, Inc.	accessdata.fda.gov
June 24, 2008	K080223	ZURA TEE SYSTEM	IYO	Substantially Equivalent	Imacor, LLC	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
August 29, 2025	97505	Class II	Ongoing	ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.	Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.	accessdata.fda.gov
September 16, 2024	95459	Class II	Ongoing	ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1	Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variability could attenuate the ultrasound signal with a potential impact on the quality of images obtained from the probes.	accessdata.fda.gov

Compare with other makers

Updated October 3, 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.