FDA Registration
Active
🇨🇳 China
MAGNETOM Vida with syngo MR XA31A
Reg #: 3004754211
·
FEI: 3004754211
·
Expires 2025
Products
3
Proprietary Names
4
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.
- Registration Number
- 3004754211
- FEI Number
- 3004754211
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- SIEMEN MRI CENTER, Gaoxin C.Ave.,2nd, Hi-Tech Industrial Park
- City
- SHENZHEN Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K203443
Owner / Operator
- Firm Name
- Siemens Healthineers AG
- Operator Number
- 8010024
- Address
- Karlheinz-Kaske-Str. 5, --
- City
- Erlangen
- State
- DE-NOTA
- Postal Code
- 91052
- Country
- DE
US Agent
- Business Name
- SIEMENS MEDICAL SOLUTIONS USA, INC.
- Contact Name
- Robert Phillips
- Address
- 40 Liberty Boulevard
- City
- MALVERN
- State
- PA
- ZIP
- 19355
- Country
- US
- [email protected]
- Phone
- 302 2359839
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | Class 2 | Radiology | No | 2021-04-05 |
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2021-04-05 |
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | Class 2 | Radiology | No | 2021-04-05 |
Proprietary Names
MAGNETOM Vida with syngo MR XA31A
MAGNETOM Lumina with syngo MR XA31A
MAGNETOM Altea with syngo MR XA31A
MAGNETOM Sola with syngo MR XA31A
Establishment Types
Manufacture Medical Device