FDA.reportPublic FDA data

TeraRecon Cardiac.Chambers.MR

Primary DI
CARDIACCHAMBERSMR1
Brand
TeraRecon Cardiac.Chambers.MR
Company
Terarecon Inc.
Model
Cardiac.Chambers.MR01
Catalog number
CARDIACCHAMBERSMR1
Device description
This Software as a Medical Device provides a user with automatic contouring of delayed enhancement and ejection fractions studies. Ejection fraction studies are segmented in short axis views for verification and accuracy.
Published
2024-12-16
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
K241312000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241312000TeraRecon Cardiac.Chambers.MR (1.0.0)Terarecon,Inc.2024-11-05QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
CARDIACCHAMBERSMR1PrimaryHIBCC0

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).

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
CARDIOVASCCALCT1TeraRecon Cardiovascular.Calcification.CT Cardiovascular.Calcification.CT01CardiovascCalCT12026-01-23
AORTACT01TeraRecon Aorta.CTAorta.CT01Aorta.CT2025-02-10
NEURO02TeraRecon NeuroNeuro02Neuro2023-06-14
AQAPS04AQAPSAQAPS04AQAPS2021-09-07
B2208430011EurekaEureka AI Results Explorer2020-11-24
B220843002A8430031EurekaEureka AI Interoperability Platform2020-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278985613NAGE Medical Systems (China) Co.,Ltd.QIH2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SQIH2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SQIH2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SQIH2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
08437021722109ADAS 3DADAS3D MEDICAL S.L.QIH2026-09-18
B720BX360HYPERDENSI1440Brainomix 360 HyperdensityBRAINOMIX LIMITEDQIH2026-09-18
00860016420922AI-CVDHeart Lung CorporationQIH2026-09-04
04262352350059DS Core CBCT AnatomyZetta25 AGQIH2026-08-26
00884838129924AV Cardiovascular Suite V1Philips Medical Systems Nederland B.V.QIH2026-08-23
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-08-18
00860006305734See-Mode TechnologiesSEE-MODE TECHNOLOGIES PTE. LTD.QIH2026-08-07
04068151012453syngo.CT Coronary CockpitSiemens Healthcare GmbHQIH2026-07-17
04068151034202syngo DynamicsSiemens Healthineers AGQIH2026-07-16
00889024707092OrthoGrid®Orthogrid Systems, Inc.QIH2026-07-15
04068151086584LungMapsSiemens Healthineers AGQIH2026-06-24
03663999000429VEA AlignEOS IMAGINGQIH2026-06-12
04068151049923MI View&GOSIEMENS MEDICAL SOLUTIONS USA, INC.QIH2026-06-10
04068151018226syngo Application SoftwareSiemens Healthcare GmbHQIH2026-05-15
00754016387128ANDIImeka Solutions IncQIH2026-05-14
00860013927820Overjet Iris Intelligent Imaging SystemOverjet, Inc.QIH2026-05-13
08437021722093ADAS 3DADAS3D MEDICAL S.L.QIH2026-05-12
00198715128956AngiowaveAngioWave Imaging, LLCQIH2026-05-09
07613336231098Opulus Lymphoma PrecisionRoche Molecular Systems, Inc.QIH2026-05-08
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.QIH2026-05-06