FDA.reportPublic FDA data

TeraRecon Neuro

Primary DI
NEURO02
Brand
TeraRecon Neuro
Company
Terarecon Inc.
Model
Neuro02
Catalog number
Neuro
Device description
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.
Published
2023-06-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K220349000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220349000TeraRecon NeuroTerarecon,Inc.2022-08-12LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
NEURO02PrimaryHIBCC0

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 quality manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021677872
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
INTUITION04IntuitionIntuition04Intuition2021-09-07
CARDIOVASCCALCT1TeraRecon Cardiovascular.Calcification.CT Cardiovascular.Calcification.CT01CardiovascCalCT12026-01-23
AORTACT01TeraRecon Aorta.CTAorta.CT01Aorta.CT2025-02-10
CARDIACCHAMBERSMR1TeraRecon Cardiac.Chambers.MRCardiac.Chambers.MR01CARDIACCHAMBERSMR12024-12-16
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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Primary DI, Brand, Company table
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09358140000093Quicktome Software SuiteOmniscient Neurotechnology Pty Ltd (o8t)LLZ2026-07-30
00866463000496STAGESpintech, Inc.LLZ2026-07-23
00854810007229iCRco Clarity ViewerIcRco, Inc.LLZ2026-07-22
17540262200102Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-07-22
17540262090161Change Healthcare CardiologyChange Healthcare Canada CompanyLLZ2026-07-21
M722CP26183V261830ClearRead CT Platform DockerRiverain Technologies, Inc.LLZ2026-07-17
00854393006084VelocityVARIAN MEDICAL SYSTEMS, INC.LLZ2026-07-16
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