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Siemens Healthcare

US

Last updated May 23, 2026

What Siemens Healthcare makes

The company manufactures full-body MRI and CT imaging systems, including superconducting magnets and hybrid PET/MRI units, alongside specialized radiological software for image processing, picture archiving (PACS), and diagnostic applications like spectroscopy, oncology, and bone analysis. Additional offerings include digital angiographic X-ray systems, removable MRI table components, and dedicated coil kits for magnetic resonance imaging.

These products are classified under FDA’s Class II and Class III regulatory categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

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US
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Catalogue (510)

Page 11 of 11
DeviceModel / ReferenceRegistriesClassStatus
syngo Imaging 11250135
FDA UDI
Class IIUnknown
Flex large 4 MR coil set 3T 08626868
FDA UDI
Class IIActive
Loop coil stand. 63 047 03137754
FDA UDI
Class IIActive
Breast Matrix MR coil kit 08626686
FDA UDI
Class IIActive
Cios Spin 10308194
FDA UDI
Class IIActive
Flex Large 4 MR coil 1.5T 10185552
FDA UDI
Class IIActive
Flex Small 18 Coil 3T 10835670
FDA UDI
Class IIActive
Mat f. flat table tops, compl. 08096989
FDA UDI
Class IIActive
Syngo.plaza Vb10a K132532
FDA 510(k)
Class IIActive
ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems K172162
FDA 510(k)
Class IIActive

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Siemens Healthcare Limited Oakville Ontario · CA FEI 3012127758