Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004754211

FEI Number

3004754211

Entity Name

SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.

City/State/Country

SHENZHEN Guangdong, CN

Establishment Address

SIEMEN MRI CENTER, Gaoxin C.Ave.,2nd, Hi-Tech Industrial Park, SHENZHEN Guangdong 518057, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Siemens Healthineers AG (Owner Number: 8010024)

Owner / Operator Contact Address

Karlheinz-Kaske-Str. 5, --, Erlangen, DE-NOTA 91052, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K082331

PMA Number

N/A

All Registered Proprietary Names

MAGNETOM Cima.X Fit MAGNETOM Flow.Ace MAGNETOM Flow.Plus XA70A MAGNETOM Combi Suite Neurosurgery for MAGNETOM systems Aera and Skyra. SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/ VERIO MAGNETOM Sola w/XJ gradient system MAGNETOM SOLA MAGNETOM Skyra MAGNETOM Aera SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS MAGNETOM Amira MAGNETOM Flow.Elite MAGNETOM Vida Fit MAGNETOM Vida MAGNETOM Flow.Rise MAGNETOM Viato.Mobile MAGNETOM Lumina Syngo MR XB10A MAGNETOM Sola MAGNETOM Altea MAGNETOM Flow.Neo MAGNETOM Sola Fit AP02 Compressed Sensing MAGNETOM Aera with syngo MR MAGNETOM Skyra with syngo MR MAGNETOM Sola with syngo MR XA51A MAGNETOM Sola Fit with syngo MR XA51A MAGNETOM Altea with syngo MR XA51A MAGNETOM Lumina with syngo MR XA50A MAGNETOM Vida Fit with syngo MR XA50A Syngo MR XB10 MAGNETOM Flow.Plus MAGNETOM Flow.Ace MAGNETOM Skyra Fit MAGNETOM Sola Fit MAGNETOM Viato.Mobile XA70A MAGNETOM Avanto Fit MAGNETOM Altea MAGNETOM Sola MAGNETOM Sola w/syngo MR XA11A MAGNETOM Altea with SW syngo MR XA11B 14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA Artis One Artis One Angiographic System ARTIS one Edition X Magnetom Spectra MAGNETOM Aera with syngo SW XA30A MAGNETOM Skyra with syngo SW XA30A MAGNETOM Prisma/ Prismafit with syngo SW XA30A syngo MR XA10A BIOGRAPH One MAGNETOM Cima.X MAGNETOM Spectra with syngo MR E11M MAGNETOM Spectra MAGNETOM Prisma with syngo MR XA60A MAGNETOM Aera with syngo MR XA60A MAGNETOM Skyra with syngo MR XA60A MAGNETOM Lumina with syngo MR XA60A MAGNETOM Prismafit with syngo MR XA60A MAGNETOM Vida with syngo MR XA60A MAGNETOM Sempra syngo MR E11S MAGNETOM Sempra with syngo MR E11S MAGNETOM Skyra with syngo MR D11 MAGNETOM Aera with syngo MR D11 MAGNETOM Aera with syngo MR D13E MAGNETOM Aera 1.5T System Head/Neck 64, Breast 18 and Body 18 long MAGNETOM Aera with software syngo MR D13A with add'l coils MAGNETOM Skyra with software syngo MR D13A with add'l coils MAGNETOM C! System MAGNETOM Artis Combi Suite Magnetom Essenza MAGNETOM Free.Max MAGNETOM Amira with software syngo MR E11S MAGNETOM ESSENZA WITH SYNGO MR D14 MAGNETOM Aera (MR E11C-AP01) MAGNETOM Aera VD13A Quiet MRI and Fast Reliable Body MRI syngo MR E11Q syngo MR E11Q SW for the MAGNETOM ESSENZA MAGNETOM Altea with syngo MR XA61A MAGNETOM Sola with syngo MR XA61A MAGNETOM Vida with syngo MR XA31A MAGNETOM Sola with syngo MR XA31A MAGNETOM Altea with syngo MR XA31A MAGNETOM Lumina with syngo MR XA31A MAGNETOM Aera - Mobile Solution with Tim Dockable Table MAGNETOM Sempra (syngo MR XA12M) MAGNETOM Amira (syngo MR XA12M) MAGNETOM Mica syngo MR E11C software for MAGNETOM Aera MR Systems syngo MR E11C syngo MR E11C software for MAGNETOM Prisma/Prismafit MR Systems syngo MR E11C software for MAGNETOM Skyra MR Systems Magnetom C! Magnetom C! System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2024-03-01
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2024-03-01
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2024-03-01
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2025-06-17
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2025-06-17
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2025-06-17
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2014-11-07
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2013-03-19
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2013-03-19
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2013-03-19
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2018-10-22
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2018-10-22
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2011-03-03
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2013-02-04
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2016-01-11
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2016-01-11
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2016-01-11
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2025-12-26
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2025-12-26
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2025-12-26
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2017-01-27
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2017-01-27
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2017-01-27
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2022-09-15
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2022-09-15
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2022-09-15
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2022-05-03
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2022-05-03
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2022-05-03
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2026-02-24
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2026-02-24
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2026-02-24
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2025-06-17
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2025-06-17
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2025-06-17
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2018-10-30
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2018-10-30
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2018-10-30
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2013-02-04
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2014-04-29
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2014-04-29
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2013-02-04
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2013-02-04
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2020-09-11
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2020-09-11
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2020-09-11
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2026-01-19
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2026-01-19
OUO	Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance	Radiology	Class 2	892.1200	2026-01-19
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2026-01-19
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2026-01-19
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2023-12-20
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2023-12-20
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2023-12-20
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2016-04-01
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2023-10-24
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2023-10-24
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2023-10-24
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2017-01-30
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2017-01-30
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2017-01-30
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2013-03-26
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2013-12-16
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2014-02-18
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2008-01-21
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2014-04-10
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2008-11-19
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2021-07-02
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2021-07-02
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2018-01-02
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2018-01-02
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2018-01-02
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2013-03-26
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2018-10-26
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2018-10-26
MOH	Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use)	Obstetrics/Gynecology	Class 2	884.2730	2018-10-26
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2014-02-17
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2016-11-21
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2016-11-21
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2016-11-21
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2023-12-26
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2023-12-26
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2023-12-26
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2021-04-05
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2021-04-05
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2021-04-05
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2019-02-18
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2019-02-18
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2019-02-18
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2019-02-15
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2019-02-15
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2019-02-15
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2016-04-18
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2011-04-20
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2013-03-28
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2013-03-28

Official Correspondent

No official correspondent registered.

US Agent Details

Robert Phillips Business: SIEMENS MEDICAL SOLUTIONS USA, INC. Email: robert.z.phillips@siemens-healthineers.com Phone: (302) 2359839

Related Public Records

Same Entity

Siemens Healthineers AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3000275399	Siemens Healthineers AG	RUDOLSTADT Thuringia, DE
3033524690	VUZE MEDICAL LTD.	TEL AVIV-JAFFA, IL
3011569702	SIEMENS X-RAY VACUUM TECHNOLOGY LTD.	Wuxi Jiangsu, CN
3002808157	Siemens Healthineers AG	ERLANGEN Bavaria, DE
3004977335	Siemens Healthineers AG	FORCHHEIM Bavaria, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K121249	Paramed S.R.L.	MULTIARRAY KIT	2012-06-12
K000935	Mri Devices Corp.	KFA-63 KNEE AND FOOT ARRAY	2000-04-07
K102889	Hitachi Medical Systems America, Inc.	HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON	2010-12-20
K110373	Esaote, S.p.A.	TEMPOROMANIBULAR COIL 15	2011-04-06
K030317	Midwest Rf, LLC	MODEL 1300GE-64: PEDIATRIC POSITIONER	2003-03-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2020	Quality Electrodynamics LLC	2	TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460
Z-0032-2020	Quality Electrodynamics LLC	2	TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453
Z-0033-2020	Quality Electrodynamics LLC	2	TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
Z-0034-2020	Quality Electrodynamics LLC	2	TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524
Z-0035-2020	Quality Electrodynamics LLC	2	TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004754211. Last updated year: 2026. Please use registration number 3004754211 when referencing this establishment in official correspondence.