FDA.reportPublic FDA data

TeraRecon Cardiovascular.Calcification.CT

Primary DI
CARDIOVASCCALCT1
Brand
TeraRecon Cardiovascular.Calcification.CT
Company
Terarecon Inc.
Model
Cardiovascular.Calcification.CT01
Catalog number
CardiovascCalCT1
Device description
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.
Published
2026-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250288000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250288000TeraRecon Cardiovascular.Calcification.CTTerarecon,Inc.2025-10-23QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
CARDIOVASCCALCT1PrimaryHIBCC0

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
INTUITION10IntuitionIntuition Mobile2020-11-24
INTUITION11IntuitionIntuition Web2020-11-24
INTUITION12IntuitionIntuition Server2020-11-24
INTUITION8IntuitionIntuition Client2020-11-24
INTUITION9IntuitionIntuition Thin Client2020-11-24
INTUITION1iNtuitionAquarius iNtuition Client2016-09-21
INTUITION2iNtuitionThinClient2016-09-21
INTUITION3iNtuitioniNtuitionReview2016-09-21
INTUITION4iNtuitioniNtuitionEMV2016-09-21
INTUITION5iNtuitioniNtuition Mobile2016-09-21
INTUITION6iNtuitionAquarius Web2016-09-21
INTUITION7iNtuitionAQNet Server2016-09-30
AQAPS1AquariusAPSAquariusAPS2016-09-21
INTUITION04IntuitionIntuition04Intuition2021-09-07
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
B220843002A8430031EurekaEureka AI Interoperability Platform2020-11-24

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Primary DI, Brand, Company table
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08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-08-18
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00860006305734See-Mode TechnologiesSEE-MODE TECHNOLOGIES PTE. LTD.QIH2026-08-07
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04068151034202syngo DynamicsSiemens Healthineers AGQIH2026-07-16
04068151086584LungMapsSiemens Healthineers AGQIH2026-06-24
03663999000429VEA AlignEOS IMAGINGQIH2026-06-12
04068151049923MI View&GOSIEMENS MEDICAL SOLUTIONS USA, INC.QIH2026-06-10
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08437021722093ADAS 3DADAS3D MEDICAL S.L.QIH2026-05-12
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07613336231098Opulus Lymphoma PrecisionRoche Molecular Systems, Inc.QIH2026-05-08
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.QIH2026-05-06
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08437023642047NemoScanSOFTWARE NEMOTEC SLQIH2026-04-23
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G703AIORTAPLAN0AiORTA - PlanVitaa Medical Solutions Inc.QIH2026-03-30