05430002070148

Nom de l'organisation

FEops NV

SRN

BE-MF-000001008

Statut du fabricant

Actif

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• CW018

  FEops HEARTguide™ uses medical images and applies computational modelling and simulation to predict the device-anatomy interaction. The technology inevitably relies on assumptions and simplifications regarding anatomy, medical procedure and biomechanical interaction. As a result, model predictions may be inaccurate in certain cases. Redo-TAVI simulations are performed using a simplified cylindrical model and are not validated against postoperative data. Do not use the provided data for preprocedural planning if the anatomical region of interest changed significantly since the acquisition of the images. FEops HEARTguide™ simulates several options. Simulations can cover a mix of appropriate and suboptimal options. Appropriate alternatives may exist. The device apposition plot is derived from the 3D model of the simulation result. The device apposition plot is not intended to predict peri-device or paravalvular leaks and/or device migration. The contact area plot (TAVI) is also derived from the 3D model and is not intended to predict conduction abnormalities. FEops HEARTguide™ does not provide functionality to evaluate the access route (e.g. transfemoral).

Marché principal en Belgique ; disponible dans 21 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

05430002070148

Basic UDI-DI

5430002070FHG-SAEH

Numéro de référence/catalogue

05430002070148

Entité d'attribution

GS1

Catégorie de risque

Classe IIa

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

—

URL des informations complémentaires

https://chrome-extension//efaidnbmnnnibpcajpcglclefindmkaj/https://heartguide.s3.eu-central-1.amazonaws.com/static/DOC-118-FHG-IFU-v14.pdf

Dimensions cliniques

• Measurements described in IFU

• Z11039092VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - MEDICAL DEVICE SOFTWARE

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

Santé des certificats sur le portefeuille de ce fabricant.