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Siemens MAGNETOM Cima.X - HSA Registration DE0510101

Access comprehensive regulatory information for Siemens MAGNETOM Cima.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 DE0510101 and owned by Siemens Healthcare GmbH. The device was registered on December 03, 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
DE0510101
Siemens MAGNETOM Cima.X
HSA Registration Number: DE0510101
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Product Description

The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0510101
Registration Date
December 03, 2024
Change Notification Approval Date
March 25, 2025
Retention Due Date
December 02, 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)
4 CH BI Breast MR Coil Kit 3T PA 36 MR Coil 3T Hand/Wrist Coil 3T 3T Shoulder 16 Large 3T Shoulder 16 Small Flex coil Interface 3T TIM Coil Interface 3.0T Head 32 MR Coil 3T 8Ch Breast Sen MR Coil Kit 3T 2/4Ch Breast Sen MR Coil Kit 3T 16Ch Breast Sen MR Coil Kit 3T Tx/Rx CP Head Coil 3T TxRx Knee 15 Coil 3T Head/Neck 64 MR Coil 3T Breast 18 MR Coil 3T Special purpose coil 4 MNO Coil interface 3.0T TxRx Knee 15 Flare MR Coil 3T Body 18 long MR coil 3T Body 18 MR Coil 3T Flex Small 4 MR coil 3T Flex Large 4 MR coil 3T Body 30 MR coil 3T Coil cable 95 3T Coil Cable 165 3T Pediatric 16, A 3T TIM Coil Direct Connect Interface 3T Head/Neck 20 shim MR Coil 3T Flex Small 18 MR Coil 3T Flex Large 18 MR Coil 3T Spine 72 respiratory MR coil 3T Spine 32 respiratory MR Coil 3T 3T Foot Ankle 16 pTx Shoulder Shape 16 3T Tx/Rx Knee 18 MR Coil 3T Head/Neck 64 shim MR Coil 3T Breast BI 7 MR Coil 3T Multi-Channel Interface BM Body 12 BM Body 18 Patient table motorized 025 cpl. Patient table mobile 025 cpl. Patient table fixed 025 cpl. 3D IGU assembly MAGNETOM Cima.X MAGNETOM Cima.X MAGNETOM Cima.X 3.0T ENDO INTERFACE 3T Loop 11 cm MR coil 3T Loop 7 cm MR coil 3T Loop 4 cm MR coil
Model Identifier(s)
10185525 10496543 10499849 10500087 10500088 10500091 10500092 10606560 10606603 10606604 10606610 10606826 10606829 10606850 10606916 10654891 10656124 10676690 10835253 10835325 10835327 10835335 10835446 10835484 10835485 10835523 10835543 10835555 10835670 10835680 10835688 10835689 10837233 10840785 10840787 11134140 11134155 11134266 11134300 11134551 11291355 11291356 11291357 11405444 11647158 11689304 11689616 8624855 8625662 8625670 8625720