666601

Nom de l'organisation

eemagine Medical Imaging Solutions GmbH

SRN

DE-MF-000005560

Statut du fabricant

Actif

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

• CW010

  visor2 is a 3D navigation system, and, as such, has no contraindications. The TMS stimulator used with visor2 may have contraindications. Warning: Before performing transcranial magnetic stimulation, read carefully the complete list of contraindications in the documentation of your TMS stimulator.

Marché principal en Allemagne ; disponible dans 31 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

+B195666601

Basic UDI-DI

++B1956666016N

Numéro de référence/catalogue

666601

Entité d'attribution

HIBCC

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

The visor2 is used to aid 3D navigation for positioning of Transcranial Magnetic Stimulation (TMS) coils over preselected brain regions in scientific research or clinical procedures. The visor2 is to be used with a compatible TMS stimulator, a compatible optical tracking system and further compatible accessories. Optionally, a compatible amplifier for measuring electrophysiological signals can be connected. The visor2 allows to record and view electrophysiological signals from the patient. It visualizes the activated functional cortex area over the anatomical images of the patient's brain based on the analysis of the patient's response after the application of a TMS pulse. The software and system on which it is installed must be operated by, or under the supervision of, a medical practitioner or investigator who has knowledge about the principles of TMS, physiology, and potential side effects, and must not be used during surgical operations.

URL des informations complémentaires

https://academy.ant-neuro.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z12109099VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER

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

Santé des certificats sur le portefeuille de ce fabricant.