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TERARECON INC

INTUITION · General and Plastic Surgery

510(k): 4 Recall: 1 UDI: 13 MAUDE: 0 Class.: 0

510(k) Clearances (4)

iNtuition-Structural Heart Module

2019-07-12

Substantially Equivalent

iNtuition-T1 Mapping and T2/T2* Mapping

2018-09-24

Substantially Equivalent

INTUITION - TDA, TVA, PARAMETRIC MAPPING

2013-12-24

Substantially Equivalent

INTUITION

2013-04-02

Substantially Equivalent

Recalls (1)

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, in

2015-01-21

Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer.

UDI Registrations (13)

Intuition

Intuition Thin Client (aka ThinClient and AquariusNET Viewer or AquariusNET ThinClient) is a client viewer with basic 2D/3D image viewing capabilities.

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.

iNtuition

ThinClient (aka AquariusNET Viewer or AquariusNET ThinClient) is a client viewer with basic 2D/3D image viewing capabilities.

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.

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.

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.

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.

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 view…

Intuition

Intuition Mobile ( aka iNtuition Mobile and AQMobile) refers to the client viewer designed for mobile devices.

iNtuition

iNtuition Mobile (aka AQMobile) refers to the client viewer designed for mobile devices.

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.

iNtuition

iNtuitionReview (aka iReview or AquariusNET Viewer) is a 2D/basic 3D image client viewer that provides multi-monitor and multi-modality image review.

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.