AI4CMR

Nom de l'organisation

AI4MedImaging Medical Solutions S.A.

SRN

PT-MF-000002951

Statut du fabricant

Actif

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• CW999

  Warnings and precautions • The physician must always review the cases even when AI4CMR classifies them as normal. • Quantitative analysis is dependent on the quality and correctness of the image source data acquisition. • The patient data must be anonymized by the third-party plugin before sending it to AI4CMR. • The patient data displayed is initially derived from the DICOM information, if available. Editing these values may affect the calculations in all modules. It is the User’s responsibility to verify this data before releasing the final results. • The user can introduce patient metadata (cine, cine recompute and flow), It is the User’s responsibility to verify this data before releasing the final results. • The user is responsible for ensuring the seed point (at Flow) is placed precisely within the intended vessel region of interest and on a structure with adequate signal clarity. • The User must keep a UPS system that provides emergency power when the input power source or mains power fails. • It is the plugin maintenance team's responsibility to execute the installation procedure to validate the communication between the User and AI4CMR. • It is AI4MedImaging’s responsibility to update/do maintenance periodically to reduce the probability of AI4CMR SW defects. • At the installation time, a copy of the digital user manual must be copied to the User’s network, under the domain of the User’s IT Manager. • In the event of loss of access credentials please follow the procedure in section 4. User account handling. • Users should read this manual before using AI4CMR. Contra-indications • AI4CMR is contraindicated to be used for post-processing of all image modalities other than cine and 2D phase-encoded images of CMR.

Marché principal en Portugal ; disponible dans 6 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

05600250059039

Basic UDI-DI

5600250059SW1ZD

Numéro de référence/catalogue

AI4CMR

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

AI4CMR is an image analysis software for post-processing of cardiac magnetic resonance images (CMR), which are used for assessment of cardiac diseases. AI4CMR uses artificial intelligence and is intended to automize cardiac segmentation allowing instantaneous quantification of ventricular volumes, myocardial mass, ejection fraction of heart ventricles and to automatically assess ventricle wall motion. AI4CMR also supports clinical diagnostics by calculating flow measurements of vascular structures in 2D phase-encoded cardiac MR images.

URL des informations complémentaires

https://ai4cmr.com/support-documentation/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

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

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• Z12040182GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES