Siemens Shanghai, Medical Equipment Ltd.
Manufacturer and brand owner in Shanghai, China. 10 device types, 31 products catalogued.
Siemens Shanghai, Medical Equipment Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers System, X-Ray, Stationary, System, X-Ray, Angiographic and 8 other device types. 31 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2008.
10device types registered with the FDA
31products catalogued under its own name
Registration
| Registered name | SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3003202425 |
| FEI number | 3003202425 |
| DUNS | 654129626 |
| Establishment type | Contract manufacturer, Complaint-file establishment, Manufacturer |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | 278 ZHOU ZHU RD |
| Postal code | 201318 |
| Country | China |
Group
Siemens Shanghai, Medical Equipment Ltd. is one of 3 plants registered under Siemens Healthineers AG.
| Plant | City | Device types |
|---|---|---|
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | 8 |
| Siemens X-RAY Vacuum Technology Ltd. | Wuxi | 2 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Device, Beam Limiting, X-Ray, Diagnostic | Class 2 | Collimator ML03, Collimator N Family, Collimator ML02 Family, Collimator Angio Family, Collimator N / N II Family, Collimator CARD Family and 7 more | 2009 | 2 |
| Holder, Radiographic Cassette, Wall-Mounted | Class 1 | Bucky Wall Stand Family | 2014 | 6 |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | Class 2 | Cios Select (VA21) Flat Panel, Cios Select Diamond, Cios Select (VA21) Flat Panel System, Cios Select (VA21) Image-Intensifier, Cios Select Flat Panel (VA21F), Axiom Artis U and 3 more | 2015 | 3 |
| Interventional Fluoroscopic X-Ray System | Class 2 | Cios Select (VA21) Flat Panel, Cios Select Diamond, Cios Select (VA21) Flat Panel System, Cios Select (VA21) Image-Intensifier, Cios Select Flat Panel (VA21F), Axiom Artis U and 3 more | 2015 | 5 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | Class 2 | MULTIX Impact C, MULTIX Impact, VA21J, MULTIX Impact E, MULTIX Impact E VB20 | 2021 | 13 |
| System, Image Processing, Radiological | Class 2 | SOMATOM CT Systems with VC50 SW – SOMATOM Perspective, SOMATOM Scope/Scope Power and SOMATOM Emotion 16 | 2019 | 16 |
| System, X-Ray, Angiographic | Class 2 | Axiom Artis U | 2015 | 7 |
| System, X-Ray, Fluoroscopic, Image-Intensified | Class 2 | Cios Select (VA21) Flat Panel, Cios Select Diamond, Cios Select (VA21) Flat Panel System, Cios Select (VA21) Image-Intensifier, Cios Select Flat Panel (VA21F), Axiom Artis U and 3 more | 2015 | 9 |
| System, X-Ray, Stationary | Class 2 | MULTIX Impact, Multix Fusion Max, MULTIX Impact C, VA21J, MULTIX Impact E, MULTIX Impact E VB20 and 4 more | 2013 | 7 |
| System, X-Ray, Tomography, Computed | Class 2 | Somatom Spirit, SOMATOM X.ceed, SOMATOM X.cite, SOMATOM Perspective (with syngo® CT VC30-easyIQ version), SOMATOM Perspective, SOMATOM go.Top with SOMARIS/10 syngo CT VA40 and 57 more | 2008 | 8 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Cios Select | OXO | 3 |
| Multix Impact | KPR | 2 |
| Table Extension | JAK | 2 |
| Multix DR-Upgrade KIT VA20 | KPR | 2 |
| Somatom Scope | JAK | 2 |
| Cios Select | OWB | 1 |
| table extension_P68 | JAK | 1 |
| Multix Impact E | KPR | 1 |
| Multix Fusion VA10 | KPR | 1 |
| Somatom Perspective Ssme | JAK | 1 |
| Somatom Spirit | JAK | 1 |
| Mattress with flat surface PHS1 | JAK | 1 |
| Somatom go.Top | JAK | 1 |
| Somatom go.Now | JAK | 1 |
| Somatom go.Open Pro | JAK | 1 |
| Multix Fusion VA30 | KPR | 1 |
| Somatom Pro.Pulse | JAK | 1 |
| Multix Fusion Max | KPR | 1 |
| Multix Impact C | KPR | 1 |
| Multix Fusion VA40 | KPR | 1 |
| Somatom Perspective | JAK | 1 |
| Scan&GO | JAK | 1 |
| Somatom Emotion 6-slice configuration | JAK | 1 |
| Somatom go.Sim | JAK | 1 |
| Somatom Emotion 16-slice configuration | JAK | 1 |
| Somatom Spirit (Ssme) | JAK | 1 |
| Multix Select DR | KPR | 1 |
| Somatom go.All | JAK | 1 |
| Somatom go.Up | JAK | 1 |
| Somatom X.ceed | JAK | 1 |
| Somatom X.cite | JAK | 1 |
Clearances
No clearance names Siemens Shanghai, Medical Equipment Ltd. as applicant. 42 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K260488 | 2026-08-31 | KPR | Traditional | Siemens Medical Solutions USA, Inc. |
| K253574 | 2026-03-20 | JAK | Traditional | Siemens Medical Solutions USA, Inc. |
| K250241 | 2025-11-04 | OWB | Traditional | Siemens Medical Solutions USA, Inc. |
| K250822 | 2025-07-03 | JAK | Traditional | Siemens Medical Solutions USA, Inc. |
| K233650 | 2024-03-26 | JAK | Traditional | Siemens Medical Solutions USA, Inc. |
| K232206 | 2023-12-06 | JAK | Traditional | Siemens Medical Solutions USA, Inc. |
| K233532 | 2023-11-29 | KPR | Special | Siemens Medical Solutions |
| K223410 | 2022-12-07 | OWB | Special | Siemens Medical Solutions USA, Inc. |
| K223409 | 2022-12-06 | OWB | Special | Siemens Medical Solutions USA, Inc. |
| K220919 | 2022-05-17 | KPR | Traditional | Siemens Medical Solutions USA, Inc. |
| K213700 | 2021-12-13 | KPR | Special | Siemens Medical Solutions USA, Inc. |
| K211373 | 2021-08-27 | JAK | Traditional | Siemens Medical Solutions USA, Inc. |
| K210309 | 2021-03-05 | OWB | Special | Siemens Medical Solutions USA, Inc. |
| K210307 | 2021-03-04 | OWB | Special | Siemens Medical Solutions USA, Inc. |
| K203345 | 2021-01-07 | KPR | Traditional | Siemens Medical Solutions USA, Inc. |
| K203340 | 2021-01-06 | KPR | Traditional | Siemens Medical Solutions USA, Inc. |
| K200524 | 2020-04-01 | JAK | Special | Siemens Medical Solutions USA, Inc. |
| K193089 | 2020-03-20 | KPR | Traditional | Siemens Medical Solutions USA, Inc. |
| K192061 | 2019-11-21 | JAK | Traditional | Siemens Medical Solutions USA, Inc. |
| K191891 | 2019-11-06 | JAK | Traditional | Siemens Medical Solutions USA, Inc. |
| K191418 | 2019-06-19 | KPR | Special | Siemens Medical Solutions USA, Inc. |
| K183548 | 2019-04-15 | JAK | Traditional | Siemens Medical Solutions USA, Inc. |
| K182517 | 2019-01-11 | KPR | Traditional | Siemens Medi Cal Solutions, Inc. |
| K181767 | 2018-08-17 | OWB | Traditional | Siemens Medical Solutions USA, Inc. |
| K173632 | 2018-04-13 | JAK | Traditional | Siemens Medical Solutions USA, Inc. |
| K163296 | 2017-03-21 | JAK | Traditional | Siemens Medical Solutions USA, Inc. |
| K162971 | 2016-11-22 | KPR | Special | Siemens Medical Solutions USA, Inc. |
| K151765 | 2016-03-25 | JAK | Traditional | Siemens Medical Solutions USA, Inc. |
| K151749 | 2016-03-18 | JAK | Traditional | Siemens Medical Solutions USA, Inc. |
| K153232 | 2016-02-10 | OWB | Special | Siemens Medical Solutions USA, Inc. |
| K151752 | 2015-11-12 | JAK | Special | Siemens Medical Solutions USA, Inc. |
| K142049 | 2014-12-18 | KPR | Traditional | Siemens Medical Solutions USA, Inc. |
| K140912 | 2014-09-15 | JAK | Traditional | Siemens Medical Solutions USA, Inc. |
| K140232 | 2014-08-14 | JAK | Traditional | Siemens Medical Solutions USA, Inc. |
| K133590 | 2014-04-30 | JAK | Traditional | Siemens Medical Solutions USA, Inc. |
| K132934 | 2014-04-10 | KPR | Traditional | Siemens Medi Cal Solutions, Inc. |
| K133424 | 2014-01-17 | JAK | Special | Siemens Medical Solutions USA, Inc. |
| K121513 | 2012-08-10 | KPR | Special | Siemens Medical Solution |
| K113287 | 2012-05-23 | JAK | Traditional | Siemens Medical Solutions USA, Inc. |
| K042328 | 2004-09-14 | JAK | Traditional | Siemens Medical Systems, Inc. |
| K040675 | 2004-06-10 | OWB | Traditional | Siemens Medical Systems, Inc. |
| K781984 | 1978-12-04 | KPW | Traditional | Siemens Healthcare Limited |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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