Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003202425

FEI Number

3003202425

Entity Name

SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.

City/State/Country

SHANGHAI, CN

Establishment Address

278 ZHOU ZHU RD, SHANGHAI 201318, 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

K121513

PMA Number

N/A

All Registered Proprietary Names

Somatom Perspective 16 & 32 slice config SOMATOM Emotion Systems - VC20 SOMATOM go.Top with SOMARIS/10 syngo CT VB20 SOMATOM go.Now with SOMARIS/10 syngo CT VB20 SOMATOM go.Up with SOMARIS/10 syngo CT VB20 SOMATOM go.Sim with SOMARIS/10 syngo CT VB20 SOMATOM go.All with SOMARIS/10 syngo CT VB20 SOMATOM go.Open Pro with SOMARIS/10 syngo CT VB20 SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB20 MULTIX Impact E SOMATOM Scope Power (with syngo® CT VC30-easyIQ version) SOMATOM Scope (with syngo® CT VC30- easyIQ version) Cios Select (VA21) Flat Panel SOMATOM go.Open Pro with SOMARIS/10 syngo CT VB10 SOMATOM X.cite with SOMARIS/10 syngo CT VB10 SOMATOM X.ceed with SOMARIS/10 syngo CT VB10 SOMATOM go.Up with SOMARIS/10 syngo CT VB10 SOMATOM go.Top with SOMARIS/10 syngo CT VB10 SOMATOM go.All with SOMARIS/10 syngo CT VB10 SOMATOM go.Now with SOMARIS/10 syngo CT VB10 SOMATOM go.Sim with SOMARIS/10 syngo CT VB10 Cios Select Cios Select (VA20) Bucky Wall Stand Family SOMATOM go.All with SOMARIS/10 syngo CT VA40 SOMATOM go.Up with SOMARIS/10 syngo CT VA40 SOMATOM go.Sim with SOMARIS/10 syngo CT VA40 SOMATOM X.cite with SOMARIS/10 syngo CT VA40 SOMATOM X.ceed with SOMARIS/10 syngo CT VA40 SOMATOM go.Top with SOMARIS/10 syngo CT VA40 SOMATOM go.Now with SOMARIS/10 syngo CT VA40 SOMATOM go.Open Pro with SOMARIS/10 syngo CT VA40 Scan&GO Software with SOMARIS/10 syngo CT VA40 SOMATOM CT Systems with VC50 SW - SOMATOM Perspective, SOMATOM Scope/Scope Power and SOMATOM Emotion 16 SOMATOM go.Now SOMATOM go.Up AXIOM ARTIS U Multix Fusion Max Multix Fusion VA30 and VA40 Multix Fusion Multix Fusion Max w/SW VF10 SOMATOM X.cite with SOMARIS/10 syngo CT VA 30 Scan&GO with SOMARIS/10 syngo CT VA 30 MULTIX Impact Cios Select Flat Panel (VA21F) Cios Select (VA21) Flat Panel System Cios Select Diamond Multix Select DR SOMATOM X.ceed SOMATOM X.cite syngo® CT 2014A (SOMARIS/5 VB42) for SOMATOM Emotion & SOMATOM Sensation family CT systems SOMATOM Perspective (with syngo® CT VC30-easyIQ version) SOMATOM Perspective Multix Fusion

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2014-05-05
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2014-02-21
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-07-07
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2022-05-18
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2022-05-18
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2016-03-22
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2021-03-08
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2021-03-08
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2021-03-08
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-03-27
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2018-08-20
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2018-08-20
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2018-08-20
IXY	Holder, Radiographic Cassette, Wall-Mounted	Radiology	Class 1	892.1880	2014-07-07
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2021-09-02
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-04-17
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-04-17
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2017-03-28
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2015-02-13
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2015-02-13
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2015-02-13
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2015-02-13
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2016-11-23
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2015-01-07
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2021-12-13
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2021-12-13
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2019-06-20
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-11-21
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2019-01-14
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2025-11-19
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2025-11-19
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2025-11-19
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2022-12-12
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2022-12-12
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2022-12-12
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2014-04-14
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2026-03-23
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2014-08-18
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2016-03-28
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2013-02-26

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
K243523	Siemens Medical Solutions USA, Inc.	NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime	2025-02-12
K781431	General Electric Co.	ELECTRIC CT/T OPERATOR DISPLAY CONSOLE	1978-09-07
K231574	FUJIFILM Healthcare Americas Corporation	Scenaria View 4.2	2023-10-12
K233583	FUJIFILM Healthcare Americas Corporation	FCT iSTREAM Phase 1	2024-04-26
K151376	Covidien, LLC	superDimension Navigation System	2015-11-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2017	Siemens Medical Solutions USA, Inc	2	Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill)applications.
Z-0014-2017	Siemens Medical Solutions USA, Inc	2	Multix Fusion VA10 Product Usage: The Multix Fusion VA10 system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including:skull, chest, abdomen and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill)applications.
Z-0007-2011	GE Medical Systems, LLC	2	HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017	Philips Medical Systems	2	Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017	Philips Medical Systems	2	Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003202425. Last updated year: 2026. Please use registration number 3003202425 when referencing this establishment in official correspondence.