MSOT Acuity Echo

Nom de l'organisation

iThera Medical GmbH

SRN

DE-MF-000010082

Statut du fabricant

Inactif

8 avertissements enregistrés — faire défiler le panneau pour tout voir.

• CW084

  Do not image eyes/direct probe towards eyes
• CW999

  Do not image patients that are experiencing photo‐toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as sulfonamides, ampicillin, tetracycline.
• CW999

  Do not image patients that are currently undergoing phototherapy.
• CW999

  Do not image patients that have a history of any photosensitive disease (e.g., porphyria, lupus erythematosus) or is undergoing treatment for a photosensitive disease and is experiencing photosensitivity
• CW999

  Do not use gas ultrasound contrast agents.
• CW999

  Do not image with organic dyes in patients with known intolerance of such dye
• CW999

  Do not image patient locations with tattoos that are in the field of view
• CW999

  Do not image the abdomen of a pregnant patient.

Marché principal en Allemagne ; disponible dans 11 pays au total.

Dénomination commerciale

MSOT Acuity Echo

Code d'UDI-DI

04262380070004

Basic UDI-DI

4262380070203TV

Numéro de référence/catalogue

SYS-MSOTACUITYechoCE2

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

The MSOT Acuity Echo System is a general-purpose, combined optoacoustic and diagnostic ultrasound imaging system intended for visualizing the real-time distribution of specific photoabsorbers in intact soft tissues. The distribution of photoabsorbers is displayed as live 2D images with B-mode ultrasound images.

URL des informations complémentaires

https://ithera-medical.com/products/clinical-research/msot-acuity-echo-new/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z11039099VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER

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