Eu Mdr Eu Md Class 1 On The Market 🇩🇪 Germany

RPS head device SGRT OFPP

gKteso GmbH · 🇩🇪 Germany
Devices (same UDI-DI)
6
Certificates
0
Countries
6
Notified Bodies
0

Basic Information

Primary DI
04260762310038
Basic UDI-DI Code
426076231RPShead4N
Reference
30700221
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market
Manufacturer
gKteso GmbH

Additional Description

The RPS Head device is intended to support rotational positioning error corrections of a patient’s head before a radiotherapy cancer treatment. Rotational error correction is possible in all three axes individually within the range of up to +/- 4.0 degrees by adjusting related knobs manually on the device. The device is to be used by radiation therapists. Before rotational error correction and subsequent treatment, the patient’s head is immobilized by a thermoplastic mask (not part of the RPS head device). The RPS head device SGRT OFPP supports SGRT workflows and Orfit 3-Point Push-Pin masks.

CND Nomenclature Codes

Code Description
Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES

Available In Countries

🇦🇹 Austria 🇧🇪 Belgium 🇩🇪 Germany 🇮🇹 Italy 🇱🇺 Luxembourg 🇳🇱 Netherlands

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