inHEART Models AI

Primary DI

03770019599068

Basic UDI-DI Code

3770019599AIv16J

Reference

V1

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

inHEART

inHEART Models AI is a medical image processing software for automatic 3D modelling of cardiac anatomy, surrounding structures, and myocardial structural substrate from medical images. Results are intended to be reviewed and, if needed, edited by inHEART trained staff with inHEART Models Shaper. inHEART Models AI is part of the inHEART Models service that provides digital 3D models of patient hearts from medical images (CT and/or MR) intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) to assist with catheter ablation procedures in patients with cardiac arrhythmias both pre- and intra- operatively.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).