9PMS3060-A02

Nom de l'organisation

DDD-Diagnostic A/S

SRN

DK-MF-000009162

Statut du fabricant

Actif

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

• CW999

  WARNING: Do not use the CardioMD IV system for any application until you are sure that the Image Performance Quality Assurance has been satisfactorily completed, and that the general maintenance program is up to date. If any part of the equipment or system is known (or suspected) to be operating improperly or wrongly-adjusted, DO NOT USE the system until a repair has been made.
• CW999

  WARNING: Do not operate the CardioMD IV system until you have read, understood and know all the safety information, safety procedures and emergency procedures contained in this Safety section. Operation of the CardioMD IV system without a proper awareness of how to use it safely could lead to fatal or other serious personal injury.
• CW999

  WARNING: Do not operate the CardioMD IV system until you have received adequate and proper training in its safe and effective operation. If you are unsure of your ability to operate this equipment safely and effectively DO NOT USE IT. Operation of this equipment without proper and adequate training could lead to fatal or other serious personal injury. It could also lead to clinical misdiagnosis.
• CW999

  WARNING: Never attempt to remove, modify, override or forcibly move any safety device on the equipment. Interfering with safety devices could lead to fatal or other serious personal injury.
• CW999

  WARNING: Do not use the CardioMD IV system for any purpose other than those for which it is intended. Operation of the CardioMD IV system for unintended purposes, or with incompatible equipment, could lead to fatal or other serious injury. It could also lead to clinical misdiagnosis.
• CW999

  Contra-indication: Do not use the system for patients who are restricted from having a nuclear medicine procedure (according to either the referring physician or the radiologist).
• CW999

  Contra-indication: Also, operators should follow the guidelines and contraindications contained in the radiopharmaceutical package insert.

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

Dénomination commerciale

non renseigné

Code d'UDI-DI

05711665002012

Basic UDI-DI

B-05711665002012

Numéro de référence/catalogue

9PMS3060-A02

Entité d'attribution

GS1

Catégorie de risque

Classe IIa

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

CardioMD IV is a dedicated gamma camera system for functional imaging of the heart.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

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.

• Z11020104FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITHOUT ‘TOTAL BODY’ ACQUISITION