Eu Mdr Eu Md Class 2b On The Market

OKS 2000

The System OKS 3000 is designed as a universal X-ray workstation and can be operated in private practices and in hospitals. The System OKS 3000 is intended for diagnostic imaging in human medicine. It is used to position a patient in X-ray diagnostics and is intended exclusively for shooting the skull, thorax, pelvis, skeleton and extremities on the lying or sitting and in conjunction with the OKS W100 also on standing patients. The operator is responsible for compliance with the regulations that apply to the installation and operation of an X-ray system. It may only be operated and maintained by persons with the necessary professional qualifications.

Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
04262357040085
Basic UDI-DI Code
426235704OKS3000-SystemYS
Reference
0203000x
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2b
Status
On The Market

Additional Description

Dieses Gerät ist für Röntgenaufnahmen von Kopf bis Fuss am stehenden, bei der Verwendung eines geeigneten Tisches am liegenden oder sitzenden Patienten bestimmt. Es gibt keine Einschränkung bzgl. der körperlichen Maße des Patienten. Das Schwenkbügelstativ ist ein fest installiertes Gerät und darf nur in medizinisch genutzten Räumen mit entsprechendem Strahlenschutz betrieben werden.

Medical Purpose

The System OKS 3000 is designed as a universal X-ray workstation and can be operated in private practices and in hospitals. The System OKS 3000 is intended for diagnostic imaging in human medicine. It is used to position a patient in X-ray diagnostics and is intended exclusively for shooting the skull, thorax, pelvis, skeleton and extremities on the lying or sitting and in conjunction with the OKS W100 also on standing patients. The operator is responsible for compliance with the regulations that apply to the installation and operation of an X-ray system. It may only be operated and maintained by persons with the necessary professional qualifications.

CND Nomenclature Codes

Code Description
Z110310 MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY

Similar Devices

Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDR).

View all