Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012127758

FEI Number

3012127758

Entity Name

Siemens Healthcare Limited

City/State/Country

Oakville Ontario, CA

Establishment Address

1577 North Service Road East, Oakville Ontario L6H 0H6, CA

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

SIEMENS MEDICAL SOLUTIONS USA, INC. (Owner Number: 9002915)

Owner / Operator Contact Address

40 Liberty Boulevard, Malvern, PA 19355, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K202966

PMA Number

N/A

All Registered Proprietary Names

ALLURA XPER FD20 Software syngo MR 819 for MAGNETOM Avanto, Espree,Symphony A Tim System, Trio A Tim System, and Verio Selenia Dimensions/3Dimensions MEGALIX CAT 125/154/40/80 Hologic Selenia 2D Mammography SOMATOM Definition AS BODY 18 MR COIL 3T DRX-REVOLUTION MOBILE X-RAY SYSTEM Medrad Mark 7 Arterion Injection System MEDRAD STELLANT CT INJECTOR SYSTEM GE Optima MR 450 MEDRAD® Spectris Solaris EP MR Injection System SOMATOM Definition Flash MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE Senographe Pristina Signa Architect

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2024-06-26
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2019-08-09
OTE	Digital Breast Tomosynthesis	Unknown	Class 3	N/A	2026-06-04
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Radiology	Class 1	892.1760	2022-10-21
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2024-06-27
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-06-26
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2022-10-21
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2024-06-26
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2024-06-25
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2024-06-25
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2018-12-05
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2024-05-21
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-06-26
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2024-06-25
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2024-06-27
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2024-06-26

Official Correspondent

No official correspondent registered.

US Agent Details

Robert Phillips Business: SIEMENS MEDICAL SOLUTIONS USA, INC. Email: shsamnamqtpmrcfurls.team@siemens-healthineers.com Phone: (302) 6319702

Related Public Records

Same Entity

SIEMENS MEDICAL SOLUTIONS USA, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1836549	SIEMENS MEDICAL SOLUTIONS USA, INC.	ANN ARBOR, MI, US
2531814	Siemens Medical Solutions USA, Inc.	Plymouth Meeting, PA, US
1034973	SIEMENS MEDICAL SOLUTIONS USA, INC.	KNOXVILLE, TN, US
3014745562	Siemens Healthcare s.r.o.	Kosice-Barca Kosicky, SK
3002619337	Siemens Healthineers Ltd.	SEONGNAM-SI Gyeonggi, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033504	General Electric Co.	GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM	2003-11-25
K013636	GE Medical Systems	SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY	2002-01-24
K250443	Siemens Healthcare GmbH	MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile	2025-06-16
K151015	Hitachi Medical Systems America, Inc.	ECHELON Oval V 5.0 MRI System	2015-07-29
K910715	Philips Medical Systems (Cleveland), Inc.	VISTA HPQ SYSTEM	1991-06-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2007	Hitachi Medical Systems America Inc	2	MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
Z-0033-2014	Philips Medical Systems (Cleveland) Inc	2	Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
Z-0389-2024	Philips North America Llc	2	Achieva 1.5T
Z-0390-2024	Philips North America Llc	2	Achieva 1.5T Conversion
Z-0391-2024	Philips North America Llc	2	Achieva 1.5T Initial System

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012127758. Last updated year: 2026. Please use registration number 3012127758 when referencing this establishment in official correspondence.