Data / Medical devices / China / Siemens Shenzhen Magnetic Resonance Ltd.
Siemens Shenzhen Magnetic Resonance Ltd.: FDA-registered device maker in SHENZHEN Guangdong, China, 54 510(k) clearances
Siemens Shenzhen Magnetic Resonance Ltd. is registered with the FDA (registration 3004754211) in SHENZHEN Guangdong, China. It lists 8 device types. The FDA files 54 510(k) clearances under its listings, the newest dated September 1, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004754211
- Address
- SIEMEN MRI CENTER, Gaoxin C.Ave.,2nd Hi-Tech Industrial Park, SHENZHEN Guangdong, China, 518057
- Owner or operator
- Siemens Healthineers AG (8010024)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- January 21, 2008
- Registered through
- 2027
- Brand names listed
- 098 1.5T Foot Ankle Coil, 098 1.5T Foot Ankle Coil Set, 1.5T Shoulder 16 Large, 14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA, AP02 Compressed Sensing, ARTIS one Edition X, Artis One, Artis One Angiographic System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | 2 | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use) | MOH | 2 | Manufacturer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| System, Tomography, Computed, Emission | KPS | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 2 | Manufacturer | accessdata.fda.gov |
| Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance | OUO | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 1, 2026 | K260758 | MAGNETOM Free.Max; MAGNETOM Free.Star | LNH | Substantially Equivalent | Siemens Shenzhen Magnetic Resonance , Ltd. | accessdata.fda.gov |
| July 31, 2026 | K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure | LNH | Substantially Equivalent | Siemens Healthineers AG | accessdata.fda.gov |
| February 23, 2026 | K260265 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | LNH | Substantially Equivalent | Siemens Shenzhen Magnetic Resonance , Ltd. | accessdata.fda.gov |
| January 15, 2026 | K253023 | BIOGRAPH One | OUO | Substantially Equivalent | Siemens Healthineers AG | accessdata.fda.gov |
| December 19, 2025 | K252838 | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise | LNH | Substantially Equivalent | Siemens Healthcare GmbH | accessdata.fda.gov |
| November 20, 2025 | K251822 | MAGNETOM Free.Max; MAGNETOM Free.Star | LNH | Substantially Equivalent | Siemens Shenzhen Magnetic Resonance , Ltd. | accessdata.fda.gov |
| June 16, 2025 | K250443 | MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile | LNH | Substantially Equivalent | Siemens Healthcare GmbH | accessdata.fda.gov |
| June 16, 2025 | K250436 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | LNH | Substantially Equivalent | Siemens Shenzhen Magnetic Resonance , Ltd. | accessdata.fda.gov |
| February 29, 2024 | K232765 | MAGNETOM Cima.X Fit | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 22, 2023 | K232535 | MAGNETOM Sola; MAGNETOM Altea | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 18, 2023 | K231587 | MAGNETOM Cima.X | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 9, 2023 | K231617 | MAGNETOM Free.Max; MAGNETOM Free.Star | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 23, 2023 | K231560 | MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 28, 2023 | K223343 | MAGNETOM Amira; MAGNETOM Sempra | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 13, 2022 | K221733 | MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 24, 2022 | K220575 | MAGNETOM Free.Max, MAGNETOM Free.Star | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 25, 2022 | K213693 | MAGNETOM Vida with syngo MR XA50A | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 1, 2021 | K210611 | MAGNETOM Free.Max | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 31, 2021 | K203443 | MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 8, 2020 | K202014 | Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 12, 2019 | K191050 | MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 15, 2019 | K190138 | MAGNETOM Aera | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 14, 2019 | K183221 | MAGNETOM Amira, MAGNETOM Sempra | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 6, 2018 | K181613 | MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 26, 2018 | K182299 | MAGNETOM Aera | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 12, 2018 | K182129 | MAGNETOM Sola | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 5, 2018 | K181322 | MAGNETOM Sola | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 13, 2018 | K173592 | MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 19, 2017 | K173600 | MAGNETOM Amira | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 27, 2017 | K163312 | MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 27, 2017 | K163211 | MAGNETOM Sempra with syngo MR E11S | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 18, 2016 | K161795 | MAGNETOM ESSENZA | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 15, 2016 | K153343 | MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit | LNH | Substantially Equivalent | Siemens Medi Cal Solutions, Inc. | accessdata.fda.gov |
| March 31, 2016 | K153447 | MAGNETOM Spectra | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 24, 2015 | K152283 | MAGNETOM Amira | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 19, 2014 | K141977 | MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 8, 2014 | K142515 | MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 28, 2014 | K133580 | ARTIS ONE | OWB | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 20, 2014 | K140253 | MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 12, 2013 | K133435 | MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 15, 2013 | K132951 | MAGNETOM AERA | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 1, 2013 | K132831 | QUIET/SILENT SCANNING SUITE | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 1, 2013 | K130262 | MAGNETOM ESSENZA WITH SYNGO MR D14 | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 5, 2012 | K121434 | SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO | LNH | Substantially Equivalent | Siemens Medi Cal Solutions, Inc. | accessdata.fda.gov |
| July 16, 2012 | K121160 | MAGNETOM SPECTRA | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 23, 2011 | K111242 | MAGNETOM AERA AND MAGNETOM SKYRA | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 11, 2011 | K103275 | SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS | MOS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 1, 2010 | K101347 | MAGNETOM AERA; MAGNETOM SKYRA | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 27, 2010 | K100141 | 14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA | MOS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 13, 2009 | K083166 | SPECIALTY COILS FOR THE MAGNETOM ESSENZA | MOS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 1, 2008 | K082331 | MAGNETOM C! | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 14, 2007 | K071925 | MAGNETOM ESSENZA | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 9, 2004 | K043030 | MAGNETOM C! MR SYSTEM | LNH | Substantially Equivalent | Siemens Medical Solutions | accessdata.fda.gov |
| July 16, 2004 | K041111 | MAGNETOM C! MR SYSTEM | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Nuclear Magnetic Resonance Spectroscopic
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of Coil, Magnetic Resonance, Specialty
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
- All makers of Interventional Fluoroscopic X-Ray System
Updated September 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.