Intuition

Primary DI
INTUITION04
Brand
Intuition
Company
Terarecon Inc.
Model
Intuition04
Catalog number
Intuition
Device description
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.
Published
2021-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121916000
K131447000
K180916000
K191585000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121916000INTUITIONTerarecon,Inc.2013-04-02LLZ
K131447000INTUITION - TDA, TVA, PARAMETRIC MAPPINGTerarecon,Inc.2013-12-24LLZ
K180916000iNtuition-T1 Mapping and T2/T2* MappingTerarecon,Inc.2018-09-24LLZ
K191585000iNtuition-Structural Heart ModuleTerarecon,Inc.2019-07-12LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
INTUITION04PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/ disc burning) and/or image manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021677872
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
CARDIOVASCCALCT1TeraRecon Cardiovascular.Calcification.CT Cardiovascular.Calcification.CT01CardiovascCalCT12026-01-23
AORTACT01TeraRecon Aorta.CTAorta.CT01Aorta.CT2025-02-10
CARDIACCHAMBERSMR1TeraRecon Cardiac.Chambers.MRCardiac.Chambers.MR01CARDIACCHAMBERSMR12024-12-16
NEURO02TeraRecon NeuroNeuro02Neuro2023-06-14
AQAPS04AQAPSAQAPS04AQAPS2021-09-07
B2208430011EurekaEureka AI Results Explorer2020-11-24
INTUITION10IntuitionIntuition Mobile2020-11-24
INTUITION11IntuitionIntuition Web2020-11-24
INTUITION12IntuitionIntuition Server2020-11-24
INTUITION8IntuitionIntuition Client2020-11-24
INTUITION9IntuitionIntuition Thin Client 2020-11-24
INTUITION1iNtuitionAquarius iNtuition Client2016-09-21
INTUITION2iNtuitionThinClient 2016-09-21
INTUITION3iNtuitioniNtuitionReview2016-09-21
INTUITION4iNtuitioniNtuitionEMV2016-09-21
INTUITION5iNtuitioniNtuition Mobile2016-09-21
INTUITION6iNtuitionAquarius Web2016-09-21
INTUITION7iNtuitionAQNet Server2016-09-30
AQAPS1AquariusAPSAquariusAPS2016-09-21
B220843002A8430031EurekaEureka AI Interoperability Platform2020-11-24

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