v1

Organization name

inHEART

SRN

FR-MF-000006723

Manufacturer status

Active

Primary placement in France; available across 1 country total.

Trade name

not provided

UDI-DI code

03770019599044

Basic UDI-DI

3770019599Shaperv1RU

Reference / catalog number

v1

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z11069092VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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