inHEART MODELS AI

GUDID 03770019599075

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.

INHEART

Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software
Primary Device ID03770019599075
NIH Device Record Key51e45e4d-6284-4ce9-bb53-0c096281c989
Commercial Distribution StatusIn Commercial Distribution
Brand NameinHEART MODELS AI
Version Model Numberv1.1.0
Company DUNS269837780
Company NameINHEART
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103770019599075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QIHAutomated Radiological Image Processing Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-17
Device Publish Date2024-04-09

Devices Manufactured by INHEART

03770019599075 - inHEART MODELS AI2024-04-17inHEART 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.
03770019599075 - inHEART MODELS AI2024-04-17 inHEART MODELS AI is a medical image processing software for automatic 3D modelling, used to pre-process medical images (acquire
03770019599082 - inHEART MODELS Shaper2024-04-16 inHEART MODELS Shaper is a standalone image processing software used to generate digital 3D models of the patient heart from med
03770019599099 - inHEART MODELS Explorer2024-04-16 inHEART Models Explorer is a a web-based 3D visualization software that permits display, review, analysis, annotation and export
03770019599020 - inHEART Models Explorer2023-10-18 inHEART Models Explorer is a a web-based 3D visualization software that permits display, review, analysis, annotation and export
03770019599006 - inHEART Models Explorer2021-04-14 inHEART Models Explorer is a web-based visualization software for display, review, annotation and export of digital 3D models se
03770019599013 - inHEART Models Shaper2021-04-14 inHEART Models Shaper is a medical image processing and visualization software for manual 3D segmentation including cardiac imag
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