contextflow ADVANCE Chest CT 2.0

Nom de l'organisation

contextflow GmbH

SRN

AT-MF-000001773

Statut du fabricant

Actif

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• CW011

  (1) Results provided by the system could contribute to image interpretation errors which in turn could contribute to an incorrect diagnosis of a patient's condition that leads to wrong treatment and ultimately causes a patient harm. (2)The system can generate incorrect outputs (within the system's performance specifications) that are potentially misleading to users such as - inaccurate detection of lung anomalies - incorrect recommendations of image patterns (3) Lists of possible diagnosis associated with specific image patterns provided by the system are not ranked by relevance (4) System does not provide image analysis results for any anatomies other than lung tissue.

Marché principal en Autriche ; disponible dans 17 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

09120107330075

Basic UDI-DI

912010733CFACHESTCT6J

Numéro de référence/catalogue

contextflow ADVANCE Chest CT 2.0

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

contextflow ADVANCE Chest CT is an AI-based, Computer Aided Detection (CADe) system for 3D medical imaging data. It provides qualitative and quantitative analysis results and corresponding reference information relevant for the identification and interpretation of lung-specific image patterns in CT (Computed Tomography) scans. To that end, the system provides the following functionalities: - SEARCH Qualitative image analysis results based on selected image regions. Visual image retrieval from a knowledge base of expert-labeled retrospective cases and pattern classification - INSIGHTS Quantitative image analysis results by automated detection, quantification and visualization of lung anomalies, specific image patterns and lung nodules - TIMELINE Longitudinal analysis of quantitative image analysis results for lung nodules and visualizations for progression or regression. - Reference Information Links to literature, articles or guidelines, tips and pitfalls, and differential diagnosis candidates

URL des informations complémentaires

https://contextflow.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z11030582RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES

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