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

Terarecon, Inc.: FDA-registered device maker in Fremont, CA, United States, 11 510(k) clearances

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

Terarecon, Inc. is registered with the FDA (registration 3014146081) in Fremont, CA, United States. It lists 3 device types. The FDA files 11 510(k) clearances under its listings, the newest dated October 23, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3014146081
Address: 39650 Liberty St, Ste 370, Fremont, CA, United States, 94538
Owner or operator: TERARECON, INC. (9039992)
Roles: Complaint file establishment, Manufacturer
First device listed: January 25, 2001
Registered through: 2026
Brand names listed: Aquarius Workstation, AquariusAPS Server, Eureka AI Interoperability Platform, Eureka AI Results Explorer, Eureka Clinical AI, Intuition, Intuition Server, Intuition-Structural Heart Module and more

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Digital Image Communications, Radiological	LMD	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Complaint file establishment, 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
October 23, 2025	K250288	TeraRecon Cardiovascular.Calcification.CT	QIH	Substantially Equivalent	Terarecon,Inc.	accessdata.fda.gov
January 23, 2025	K243158	TeraRecon Aorta.CT (1.1.0)	QIH	Substantially Equivalent	Terarecon,Inc.	accessdata.fda.gov
November 5, 2024	K241312	TeraRecon Cardiac.Chambers.MR (1.0.0)	QIH	Substantially Equivalent	Terarecon,Inc.	accessdata.fda.gov
August 12, 2022	K220349	TeraRecon Neuro	LLZ	Substantially Equivalent	Terarecon,Inc.	accessdata.fda.gov
July 12, 2019	K191585	iNtuition-Structural Heart Module	LLZ	Substantially Equivalent	Terarecon,Inc.	accessdata.fda.gov
September 24, 2018	K180916	iNtuition-T1 Mapping and T2/T2* Mapping	LLZ	Substantially Equivalent	Terarecon,Inc.	accessdata.fda.gov
December 24, 2013	K131447	INTUITION - TDA, TVA, PARAMETRIC MAPPING	LLZ	Substantially Equivalent	Terarecon,Inc.	accessdata.fda.gov
April 2, 2013	K121916	INTUITION	LLZ	Substantially Equivalent	Terarecon,Inc.	accessdata.fda.gov
May 15, 2006	K061214	AQUARIUSAPS SERVER	LLZ	Substantially Equivalent	Terarecon,Inc.	accessdata.fda.gov
September 13, 2001	K012086	AQUARIUSNET SERVER	LLZ	Substantially Equivalent	Terarecon,Inc.	accessdata.fda.gov
May 8, 2001	K011142	AQUARIUS WORKSTATION	LLZ	Substantially Equivalent	Terarecon,Inc.	accessdata.fda.gov

Compare with other makers

Updated October 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.