Pure Global AI
HSA · registration DE0509551

Siemens MAGNETOM Terra.X

SingaporeRadiology / ImagingClass BSiemens Healthcare GmbH
Verified
Official record identity
Registration number
DE0509551
Model name
1Tx32Rx Head Coil 7T clinic S; 1Tx28Rx Knee Coil 7T clinic S; 23Na 1Tx32Rx/1HTxRx Head Coil Set 7T; 31P/1H TxRx Flex Loop Coil Set 7T; MAGNETOM Terra.X; MAGNETOM Terra.X Upgrade; 8Tx32Rx Head Coil 7T clinic S
Model identifier
11250925; 11250933; 11371302; 11371304; 11371477; 11371478; 11371594
Registration date
July 19, 2024
Classification
Risk class
Class B
Official value: CLASS B
Published category
Radiology / Imaging
View exact category matches →
Published parties
Product owner
Siemens Healthcare GmbH
Registrant / registration holder
SIEMENS HEALTHCARE PTE. LTD.
Official description

The MAGNETOM Terra.X system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, and that displays the internal structure and/or function of the head or extremities. Other physical parameters derived from the images may also be produced. Depending on the region of interest, contrast agents may be used.

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.