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Siemens MAGNETOM Terra.X - HSA Registration DE0509551

Access comprehensive regulatory information for Siemens MAGNETOM Terra.X in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509551 and owned by Siemens Healthcare GmbH. The device was registered on July 19, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0509551
Siemens MAGNETOM Terra.X
HSA Registration Number: DE0509551
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Product 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.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0509551
Registration Date
July 19, 2024
Retention Due Date
July 18, 2025
Product Owner
Short Name
Siemens Healthcare GmbH
Address
Henkestr. 127, 91052 Erlangen, GERMANY
Registrant
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Importer
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model Information
Model Name(s)
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(s)
11250925 11250933 11371302 11371304 11371477 11371478 11371594