FDA Registration
Active
🇨🇳 China
MAGNETOM Vida with syngo MR XA60A
Reg #: 3004754211
·
FEI: 3004754211
·
Expires 2025
Products
3
Proprietary Names
6
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
- K231560
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 | 2023-10-24 |
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | Class 2 | Radiology | No | 2023-10-24 |
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2023-10-24 |
Proprietary Names
MAGNETOM Vida with syngo MR XA60A
MAGNETOM Skyra with syngo MR XA60A
MAGNETOM Aera with syngo MR XA60A
MAGNETOM Lumina with syngo MR XA60A
MAGNETOM Prismafit with syngo MR XA60A
MAGNETOM Prisma with syngo MR XA60A
Establishment Types
Manufacture Medical Device