Methinks Stroke Suite

Nom de l'organisation

Methinks Software SL

SRN

ES-MF-000023690

Statut du fabricant

Actif

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• CW010

  Warnings and Precautions: - Identification of suspected findings is not for diagnostic use beyond notification. - Methinks Stroke Suite is limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis. - Key images provided through the notification module are for informational purposes only and not intended for diagnostic use beyond notification. - For non-enhanced images, NCCT-LVO and NCCT-ICH, soft tissue reconstruction kernels must be used.

Marché principal en Espagne ; disponible dans 1 pays au total.

Dénomination commerciale

Methinks Stroke Suite

Code d'UDI-DI

08437023475010

Basic UDI-DI

8437023475MSSEUBH

Numéro de référence/catalogue

N/A

Entité d'attribution

GS1

Catégorie de risque

Classe IIb

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Intended Use: Methinks Stroke Suite is a radiological computer aided triage and notification system indicated for use in the analysis of Non-Contrast Computed Tomography (NCCT) images and Computed Tomography Angiography (CTA) images of the head. The device is intended to assist trained physicians in workflow triage by notification of suspected positive cases of Acute Intracranial Hemorrhage (ICH) and Large Vessel Occlusion (LVO) in emergency settings. It works in parallel with the ongoing standard of care image interpretation and the result of the device shall be used in conjunction with other patient information and based on professional judgement. The device shall not be used for full patient evaluation or relied upon to make or confirm the diagnosis. It shall be used to alert physicians about a high probability of stroke-related findings (Large Vessel Occlusion (LVO) and/or acute Intracranial Hemorrhage (ICH)) in order to prioritize the study reading. The product is limited to analysis of imaging for the narrow detection of Acute Stroke (AS) findings, and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z11030582RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES

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