VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

Primary DI

03770019599044

Basic UDI-DI Code

3770019599Shaperv1RU

Reference

v1

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

inHEART

inHEART Models Shaper is a medical image processing software for 3D modelling of cardiac anatomy, surrounding structures, and myocardial structural substrate from CT and/or MR images that is intended to be used by inHEART trained staff. inHEART Models Shaper 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).