FDA.reportPublic FDA data

TeraRecon Aorta.CT

Primary DI
AORTACT01
Brand
TeraRecon Aorta.CT
Company
Terarecon Inc.
Model
Aorta.CT01
Catalog number
Aorta.CT
Device description
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.
Published
2025-02-10
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
K243158000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243158000TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.2025-01-23QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
AORTACT01PrimaryHIBCC0

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
INTUITION04IntuitionIntuition04Intuition2021-09-07
CARDIOVASCCALCT1TeraRecon Cardiovascular.Calcification.CT Cardiovascular.Calcification.CT01CardiovascCalCT12026-01-23
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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Primary DI, Brand, Company table
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07613336231098Opulus Lymphoma PrecisionRoche Molecular Systems, Inc.QIH2026-05-08
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.QIH2026-05-06
B720BX360ECTA1430e-CTABRAINOMIX LIMITEDQIH2026-05-06
00860010264638EZRA PLEXO SOFTWAREEzra Ai, Inc.QIH2026-05-05
08437023642047NemoScanSOFTWARE NEMOTEC SLQIH2026-04-23
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00860000171243SubtleHD(MR)Subtle Medical, Inc.QIH2026-04-09
08800124700136SwiftMRAIRS Medical Inc.QIH2026-04-01
G703AIORTAPLAN0AiORTA - PlanVitaa Medical Solutions Inc.QIH2026-03-30
B720BX360ECTA1210Brainomix 360 e-CTABRAINOMIX LIMITEDQIH2026-03-30
08800066200626MEDIHUB PROSTATEJLK, Inc.QIH2026-03-25
00884838122154EchoNavigatorPhilips Medical Systems Nederland B.V.QIH2026-03-25
10603295562108VELYS Hip NavigationDEPUY ORTHOPAEDICS, INC.QIH2026-03-24
08800130400303Neurophet AQUA AD PlusNEUROPHET Inc.QIH2026-02-24
G762AISAPCARDIOV10AISAP Cardio V1.0AISAP LTDQIH2026-02-18
B720BX360ECTA1420e-CTABRAINOMIX LIMITEDQIH2026-02-03
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290042481PA2-9SSAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290042726CA2-13MSAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290065473EV2-12SAMSUNG MEDISON CO., LTD.QIH2026-01-28
00195278932358Spectral Bone MarrowGE Medical Systems, L.L.C.QIH2026-01-26
00198953113554LOGIQGE Ultrasound Korea Ltd.QIH2026-01-26
00198953113493LOGIQGE Ultrasound Korea Ltd.QIH2026-01-21