Data / Medical devices / China / Siemens Shanghai, Medical Equipment Ltd.
Siemens Shanghai, Medical Equipment Ltd.: FDA-registered device maker in Shanghai, China, 42 510(k) clearances
Siemens Shanghai, Medical Equipment Ltd. is registered with the FDA (registration 3003202425) in Shanghai, China. It lists 10 device types. The FDA files 42 510(k) clearances under its listings, the newest dated August 31, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003202425
- Address
- 278 Zhou Zhu RD, Shanghai, China, 201318
- Owner or operator
- Siemens Healthineers AG (8010024)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- March 21, 2008
- Registered through
- 2027
- Brand names listed
- AXIOM ARTIS U, Bucky Wall Stand Family, Cios Select, Cios Select (VA20), Cios Select (VA21) Flat Panel, Cios Select (VA21) Flat Panel System, Cios Select (VA21) Image Intensifier, Cios Select (VA21) Image-Intensifier and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Beam Limiting, X-Ray, Diagnostic | KPW | 2 | Manufacturer | accessdata.fda.gov |
| Holder, Radiographic Cassette, Wall-Mounted | IXY | 1 | Contract manufacturer | accessdata.fda.gov |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Angiographic | IZI | 2 | Complaint file establishment | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, X-Ray, Stationary | KPR | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 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 |
|---|---|---|---|---|---|---|
| August 31, 2026 | K260488 | MULTIX Impact; MULTIX Impact C | KPR | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 20, 2026 | K253574 | SOMATOM X.cite; SOMATOM X.ceed | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 4, 2025 | K250241 | Cios Select | OWB | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 3, 2025 | K250822 | SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 26, 2024 | K233650 | SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 6, 2023 | K232206 | SOMATOM Pro.Pulse | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 29, 2023 | K233532 | MULTIX Impact E | KPR | Substantially Equivalent | Siemens Medical Solutions | accessdata.fda.gov |
| December 7, 2022 | K223410 | Cios Select (VA21) Flat Panel | OWB | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 6, 2022 | K223409 | Cios Select (VA21) Image Intensifier | OWB | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| May 17, 2022 | K220919 | MULTIX Impact E | KPR | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 13, 2021 | K213700 | MULTIX Impact, MULTIX Impact C | KPR | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 27, 2021 | K211373 | SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and SOMATOM X.ceed, Scan&GO Software | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 5, 2021 | K210309 | Cios Select (VA21) Flat Panel | OWB | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 4, 2021 | K210307 | Cios Select (VA21) Image Intensifier | OWB | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 7, 2021 | K203345 | MULTIX Impact | KPR | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 6, 2021 | K203340 | MULTIX Impact C | KPR | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 1, 2020 | K200524 | SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 20, 2020 | K193089 | MULTIX Impact | KPR | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 21, 2019 | K192061 | SOMATOM Go Platform SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 6, 2019 | K191891 | SOMATOM X.cite | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 19, 2019 | K191418 | Multix Fusion Max | KPR | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 15, 2019 | K183548 | SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 11, 2019 | K182517 | MULTIX Impact | KPR | Substantially Equivalent | Siemens Medi Cal Solutions, Inc. | accessdata.fda.gov |
| August 17, 2018 | K181767 | Cios Select | OWB | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 13, 2018 | K173632 | SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 21, 2017 | K163296 | SOMATOM go.Up, SOMATOM go.Now | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 22, 2016 | K162971 | Multix Fusion Max | KPR | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 25, 2016 | K151765 | SOMATOM Perspective | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 18, 2016 | K151749 | somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version) | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 10, 2016 | K153232 | Cios Select | OWB | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 12, 2015 | K151752 | SOMATOM Emotion 6/16 | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 18, 2014 | K142049 | MULTIX FUSION VA30 & VA40 | KPR | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 15, 2014 | K140912 | SOMATOM SCOPE/SOMATOM SCOPE POWER | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 14, 2014 | K140232 | SYNGO CT 2014A (SOMARIS/5 VB42) FOR SOMATOM EMOTION & SENSATION FAMILY CT | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 30, 2014 | K133590 | SOMATOM PERSPECTIVE | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 10, 2014 | K132934 | MULTIX SELECT DR | KPR | Substantially Equivalent | Siemens Medi Cal Solutions, Inc. | accessdata.fda.gov |
| January 17, 2014 | K133424 | SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16 | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 10, 2012 | K121513 | MULTIX FUSION | KPR | Substantially Equivalent | Siemens Medical Solution | accessdata.fda.gov |
| May 23, 2012 | K113287 | SOMATOM PERSPECTIVE | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 14, 2004 | K042328 | SOMATOM SPIRIT | JAK | Substantially Equivalent | Siemens Medical Systems, Inc. | accessdata.fda.gov |
| June 10, 2004 | K040675 | AXIOM ARTIS U | OWB | Substantially Equivalent | Siemens Medical Systems, Inc. | accessdata.fda.gov |
| December 4, 1978 | K781984 | COLLIMATOR, HEART CONTOUR | KPW | Substantially Equivalent | Siemens Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of System, X-Ray, Stationary
- All makers of System, X-Ray, Tomography, Computed
- All makers of Holder, Radiographic Cassette, Wall-Mounted
- All makers of Device, Beam Limiting, X-Ray, Diagnostic
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
Updated August 31, 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.