inHEART MODELS AI

Primary DI
03770019599075
Brand
inHEART MODELS AI
Company
INHEART
Model
v1.1.0
Device description
inHEART MODELS AI is a medical image processing software for automatic 3D modelling, used to pre-process medical images (acquired only by CT devices).inHEART Models AI results are intended to be reviewed and, if needed, edited by inHEART trained staff with inHEART Models Shaper.inHEART MODELS AI is part of inHEART MODELS that is intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the clinicians are solely responsible for making all final patient management decisions.
Published
2024-04-09
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
LLZSystem, Image Processing, Radiological
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231683000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231683000inHEART ModelsInheart, Sas2024-02-29QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03770019599075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770019599075037700195990753770019599075

GMDN Terms#

Term, Definition table
TermDefinition
Image segmentation application softwareAn application software program intended to convert large volumes of slice-based images into manageable three-dimensional (3-D) models of anatomical structures. It is typically used in an electrophysiology (EP) procedure (e.g., a cardiac mapping) to accept DICOM3 images from computed tomography (CT) and magnetic resonance imaging (MRI) scanners. Once the images are imported, a 3-D model can be extracted in a process called segmentation (the isolation of an object of interest) for easy viewing and manipulation during the EP procedure. This device is typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
269837780
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770019599112inHEART Models Explorerv3.0.0NA2025-07-15
03770019599099inHEART MODELS Explorerv2.8.02024-04-08
03770019599037inHEART Models Shaperv1.4.02022-12-12
03770019599020inHEART Models Explorerv2.5.02022-12-12
03770019599006inHEART Models Explorerv2.2.12021-04-06
03770019599013inHEART Models Shaperv1.2.02021-04-06
03770019599082inHEART MODELS Shaperv1.8.02024-04-08

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