TeraRecon Cardiovascular.Calcification.CT
Terarecon,Inc.
Terarecon, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014146081 | 3014146081 | Terarecon, Inc. | 1 | N | 2026-01-01 | 4309 Emperor Blvd., Suite 310 Durham NC US 27703 |
| 2954793 | 3003243710 | TERARECON, INC. | 1 | N | 2020-04-25 | 39141 Civic Center Drive, Suite 240 Fremont CA US 94538 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 237898 | 1863341753 | K250288 | TeraRecon Cardiovascular.Calcification.CT | QIH | 2025-10-23 |
| 237898 | 1970979134 | K243158 | TeraRecon Aorta.CT (1.1.0) | QIH | 2025-01-23 |
| 237898 | 1214490803 | K241312 | TeraRecon Cardiac.Chambers.MR (1.0.0) | QIH | 2024-11-05 |
| 237898 | 1289405178 | K220349 | TeraRecon Neuro | LLZ | 2022-08-12 |
| 57056 | 1796626819 | K191585 | iNtuition-Structural Heart Module | LLZ | 2019-07-12 |
| 237898 | 1796626819 | K191585 | iNtuition-Structural Heart Module | LLZ | 2019-07-12 |
| 237898 | 1567285377 | K190826 | |||
| 57056 | 1718331473 | K180916 | iNtuition-T1 Mapping and T2/T2* Mapping | LLZ | 2018-09-24 |
| 237898 | 1718331473 | K180916 | iNtuition-T1 Mapping and T2/T2* Mapping | LLZ | 2018-09-24 |
| 57056 | 1300124555 | K131447 | INTUITION - TDA, TVA, PARAMETRIC MAPPING | LLZ | 2013-12-24 |
| 237898 | 1300124555 | K131447 | INTUITION - TDA, TVA, PARAMETRIC MAPPING | LLZ | 2013-12-24 |
| 57056 | 1389378099 | K121916 | INTUITION | LLZ | 2013-04-02 |
| 237898 | 1389378099 | K121916 | INTUITION | LLZ | 2013-04-02 |
| 237898 | 1978672307 | K061214 | AQUARIUSAPS SERVER | LLZ | 2006-05-15 |
| 57056 | 1978672307 | K061214 | AQUARIUSAPS SERVER | LLZ | 2006-05-15 |
| 237898 | 1111259190 | K012086 | AQUARIUSNET SERVER | LLZ | 2001-09-13 |
| 57056 | 1111259190 | K012086 | AQUARIUSNET SERVER | LLZ | 2001-09-13 |
| 237898 | 1083262196 | K011142 | AQUARIUS WORKSTATION | LLZ | 2001-05-08 |
| 57056 | 1083262196 | K011142 | AQUARIUS WORKSTATION | LLZ | 2001-05-08 |
| 237898 | 1449015894 |
Product Codes Associated With Registrations#
PMN#
TeraRecon Aorta.CT (1.1.0)
Terarecon,Inc.
TeraRecon Cardiac.Chambers.MR (1.0.0)
Terarecon,Inc.
TeraRecon Neuro
TeraRecon, Inc
Neuro.Al Algorithm
TeraRecon, Inc.
INtuition-Structural Heart Module
TeraRecon Inc.
INtuition-T1 Mapping And T2/T2* Mapping
TeraRecon Inc.,
INTUITION - TDA, TVA, PARAMETRIC MAPPING
TERARECON, INC.
INTUITION
TERARECON, INC.
AQUARIUSAPS SERVER
TERARECON, INC.
AQUARIUSNET SERVER
TERARECON, INC.
AQUARIUS WORKSTATION
TERARECON, INC.
IIVS INTEGRATED IMAGE VIEWING STATION
TERARECON, INC.
RTR-2000/RTR-4000
TERARECON, INC.
GUDID#
Intuition - Intuition (also referred to as Aquarius Intuition) is a medical device comprised of two stand-alone software components: a server software backend (Intuition Server) which performs complex image post processing and client viewer software (Intuition Client Viewers) that provides a user interface, enabling the user to view medical image data and associated derived metadata. The Intuition client viewer/server software enables 2D/3D/4D (3D with the dimension of time) image review, volume rendering, communications, storage, reporting, and image post processing. The Intuition software is used with off-the-shelf hardware, including a computer, monitor, keyboard and mouse.Intuition is comprised of six (6) separate client viewers: Intuition Client with Emergency Lung Docker, Intuition Thin Client, Intuition Review, Intuition EMV, Intuition Web Viewer, and Intuition Mobile.
2021-09-07
TeraRecon Cardiovascular.Calcification.CT - TeraRecon Cardiovascular.Calcification.CT is intended to provide an automatic 3D segmentation of calcified plaques within the coronary arteries and outputs a mask for calcium scoring systems to use for calculations. The results of TeraRecon Cardiovascular.Calcification.CT are intended to be used in conjunction with other patient information by trained professionals who are responsible for making any patient management decision per the standard of care.
2026-01-23
TeraRecon Aorta.CT - TeraRecon Aorta.CT is intended to provide an automatic 3D segmentation and label anatomical landmarks of the Aorta. The results of TeraRecon Aorta.CT are intended to be used in conjunction with other patient information by trained professionals who are responsible for making any patient management decision per the standard of care.
2025-02-10
TeraRecon Cardiac.Chambers.MR - This Software as a Medical Device provides a user with automatic contouring of delayed enhancement and ejection fractions studies. Ejection fraction studies are segmented in short axis views for verification and accuracy.
2024-12-16
TeraRecon Neuro - TeraRecon Neuro allows motion correction and processes, calculates and outputs brain perfusion analysis results for functional, dynamic, and derived imaging datasets acquired with CT or MRI. TeraRecon Neuro results are used for the analysis of dynamic brain perfusion image data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to brain tissue perfusion, vascular assessment and tissue blood volume.
2023-06-14
AQAPS - AQAPS, also known as AquariusAPS Server, is a stand-alone medical device software which performs various kinds of data processing on incoming DICOM data sets, according to user pre-configured rules and schedules.
2021-09-07
Eureka - Eureka AI Results Explorer (aka Northstar AI Results Explorer and Northstar) is a zero-footprint, web-based software device indicated for use in clinical settings where medical images and image-derived metadata can be accessed or visualized to aid healthcare professionals in diagnosis and patient management decision making. Eureka AI Results Explorer’s web interfaces can obtain and consume both DICOM and non-DICOM image-derived metadata generated by Artificial Intelligence (AI) or computer vision algorithms.
2020-11-24
Intuition - Intuition Client (aka Aquarius iNtuition Client, AQi, Aquarius Workstation, or Aquarius Workstation iNtuition Client) is the most comprehensive client viewer with 2D/3D/4D image processing and visualization capabilities.
2020-11-24
Intuition - Intuition Mobile ( aka iNtuition Mobile and AQMobile) refers to the client viewer designed for mobile devices.
2020-11-24
Intuition - Intuition Web (aka AquariusWeb Viewer and AqWeb or Web Viewer, marketing term) is a version of Intuition EMV (aka iNtuitionEMV) with a focus on 3D rendering, additionally providing workflow and scene support.
2020-11-24
Intuition - The Intuition Server (aka AquariusNET Server and iNtuition Server) receives, stores, transmits and post-processes medical images from acquisition devices in DICOM and non-DICOM formats.
2020-11-24
Intuition - Intuition Thin Client (aka ThinClient and AquariusNET Viewer or AquariusNET ThinClient) is a client viewer with basic 2D/3D image viewing capabilities.
2020-11-24
iNtuition - Aquarius iNtuition Client (aka AQi, Aquarius Workstation, or Aquarius Workstation iNtuition Client) is the most comprehensive client viewer with 2D/3D/4D image processing and visualization capabilities.
2016-09-21
iNtuition - ThinClient (aka AquariusNET Viewer or AquariusNET ThinClient) is a client viewer with basic 2D/3D image viewing capabilities.
2016-09-21
iNtuition - iNtuitionReview (aka iReview or AquariusNET Viewer) is a 2D/basic 3D image client viewer that provides multi-monitor and multi-modality image review.
2016-09-21
iNtuition - iNtuitionEMV (aka iEMV) is a “zero footprint” 2D/basic 3D image client viewer running within a web browser. Limited to the context of iEMV usage on a mobile device, it is referred to as iEMV Mobile.
2016-09-21
iNtuition - iNtuition Mobile (aka AQMobile) refers to the client viewer designed for mobile devices.
2016-09-21
iNtuition - AquariusWeb Viewer (aka AqWeb or Web Viewer, marketing term) is a version of iNtuitionEMV with a focus on 3D rendering, additionally providing workflow and scene support.
2016-09-21
iNtuition - The AquariusNET Server, also known as iNtuition Server, receives, stores, transmits and post-processes medical images from acquisition devices, in both DICOM and non-DICOM format.
2016-09-30
AquariusAPS - The AquariusAPS server is a stand-alone medical device software which performs various kinds of data processing on incoming DICOM data sets, according to user pre-configured rules and schedules.
2016-09-21
Eureka - An application software program designed to function as a portal to allow software providers to make available radiological interpretive software [typically artificial intelligence (AI) based] for radiology professionals to access, use, evaluate, and compare. It is intended to facilitate distribution and hospital implementation of algorithms designed to assist image interpretation within a healthcare facility.
2020-11-24