Terarecon, Inc.
Fremont, CA, US
Terarecon, Inc. appears in FDA device records in Fremont, CA. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Terarecon, Inc. between 1998 and 2025. The busiest year on record is 2001, with 2. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 2000 | 1 |
| 2001 | 2 |
| 2006 | 1 |
| 2013 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250288 | TeraRecon Cardiovascular.Calcification.CT | QIH | Substantially Equivalent | |
| K243158 | TeraRecon Aorta.CT (1.1.0) | QIH | Substantially Equivalent | |
| K241312 | TeraRecon Cardiac.Chambers.MR (1.0.0) | QIH | Substantially Equivalent | |
| K220349 | TeraRecon Neuro | LLZ | Substantially Equivalent | |
| K200750 | Neuro.Al Algorithm | LLZ | Substantially Equivalent | |
| K191585 | iNtuition-Structural Heart Module | LLZ | Substantially Equivalent | |
| K180916 | iNtuition-T1 Mapping and T2/T2* Mapping | LLZ | Substantially Equivalent | |
| K131447 | INTUITION - TDA, TVA, PARAMETRIC MAPPING | LLZ | Substantially Equivalent | |
| K121916 | INTUITION | LLZ | Substantially Equivalent | |
| K061214 | AQUARIUSAPS SERVER | LLZ | Substantially Equivalent | |
| K012086 | AQUARIUSNET SERVER | LLZ | Substantially Equivalent | |
| K011142 | AQUARIUS WORKSTATION | LLZ | Substantially Equivalent | |
| K994329 | IIVS INTEGRATED IMAGE VIEWING STATION | LMD | Substantially Equivalent | |
| K974307 | RTR-2000/RTR-4000 | JAK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014146081 | 3014146081 | Terarecon, Inc. | 39650 Liberty St, Ste 370, Fremont, CA 94538 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1070-2015 | Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture Archiving and Communications System; Findings Workflow Modules 4.4.11.82.6784, 4.4.11.116.7134, 4.4.11.144.7589. A fully-configured iNtuition system is capable of various image processing and visualization functions, including basic features and advanced post processing modules. The system can be configured as a server with some, all, or none of its optional features disabled. The intended use of the device is to provide solutions to various medical image-analysis and viewing problems, which come about as modalities generate more and more images. It also supports image distribution over networks, and is DICOM compliant. | Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain