inheart.frinHEART Models
Inheart, Sas
INHEART
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3018302800 | 3018302800 | INHEART | 1 | N | 2026-01-01 | IHU Liryc - Hopital Xavier Arnozan Avenue du Haut Leveque Pessac Gironde FR 33600 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 03770019599006 | inHEART Models Explorer - inHEART Models Explorer is a web-based visualization software for display, review, annotation and export of digital 3D models segmented from medical images including cardiac images (CT and/or MR). It is intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians), as well as by inHEART trained staffs.inHEART Models Explorer is part of the inHEART Models service that provides digital 3D models from medical images (CT and/or MR) intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians).Clinicians are solely responsible for making all final patient management decisions. | 9999999999 | support@inheart.fr |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 290462 | 1034460857 | K231683 | inHEART Models | QIH | 2024-02-29 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QIH | 1 | 2024-02-29 |
PMN#
inHEART MODELS
Inheart, Sas
GUDID#
inHEART Models Explorer - inHEART Models Explorer is a a web-based 3D visualization software that permits display, review, analysis, annotation and export of the cardiac 3D models generated from inHEART Models Shaper.inHEART Models Explorer 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.
2025-07-15
inHEART MODELS Explorer - inHEART Models Explorer is a a web-based 3D visualization software that permits display, review, analysis, annotation and export of the cardiac 3D models generated from inHEART MODELS Shaper.inHEART MODELS Explorer 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.
2024-04-08
inHEART Models Shaper - inHEART MODELS Shaper is a standalone image processing software used to generate digital 3D models of the patient heart from medical images acquired by CT and/or MR devices.inHEART MODELS Shaper 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 users are solely responsible for making all final patient management decisions.
2022-12-12
inHEART Models Explorer - inHEART Models Explorer is a a web-based 3D visualization software that permits display, review, analysis, annotation and export of the cardiac 3D models generated from inHEART MODELS Shaper.inHEART Models Explorer 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.
2022-12-12
inHEART Models Explorer - inHEART Models Explorer is a web-based visualization software for display, review, annotation and export of digital 3D models segmented from medical images including cardiac images (CT and/or MR). It is intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians), as well as by inHEART trained staffs.inHEART Models Explorer is part of the inHEART Models service that provides digital 3D models from medical images (CT and/or MR) intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians).Clinicians are solely responsible for making all final patient management decisions.
2021-04-06
inHEART Models Shaper - inHEART Models Shaper is a medical image processing and visualization software for manual 3D segmentation including cardiac images. It provides simple image review software functionality for basic medical image processing and manipulation, such as grayscale window and level, zoom and pan, image reformat, thresholding or user delineated geometric measurements (distance and volume). It is intended to be used by inHEART trained staffs.inHEART Models Shaper is part of the inHEART Models service that provides digital 3D models from medical images (CT and/or MR) intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians).Clinicians are solely responsible for making all final patient management decisions.
2021-04-06
inHEART MODELS AI - 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.
2024-04-09
inHEART MODELS Shaper - inHEART MODELS Shaper is a standalone image processing software used to generate digital 3D models of the patient heart from medical images acquired by CT and/or MR devices.inHEART MODELS Shaper 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 users are solely responsible for making all final patient management decisions.
2024-04-08