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HSA · registration DE0507812

Siemens SOMATOM X.ceed

SingaporeRadiology / ImagingClass CSiemens Healthcare GmbH
Official record identity
Registration number
DE0507812
Model name
P61-DMS-high; Tube Collimator Zi81; Tube Collimator Zi81 SF; SOMATOM X.ceed; IVJ Intervention Joystick wired
Model identifier
11020190; 11329903; 11329904; 11330002; 11331151
Registration date
February 23, 2023
Classification
Risk class
Class C
Official value: CLASS C
Published category
Radiology / Imaging
Published parties
Registrant / registration holder
SIEMENS HEALTHCARE PTE. LTD.
Official description

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis. This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies.

Additional source fields
Product owner address
Henkestr. 127, 91052 Erlangen, Germany
Registrant address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, Singapore 348615
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.