FDA Registration
Active
🇺🇸 United States
syngo.MI Workplace
Reg #: 1423253
·
FEI: 1000514697
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SIEMENS MEDICAL SOLUTIONS USA, INC.
- Registration Number
- 1423253
- FEI Number
- 1000514697
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2501 NORTH BARRINGTON RD.
- City
- Hoffman Estates
- State
- IL
- ZIP
- 60192
- Country
- US
Regulatory Submissions
- 510(k) Number
- K151192
Owner / Operator
- Firm Name
- SIEMENS MEDICAL SOLUTIONS USA, INC.
- Operator Number
- 9002915
- Address
- 40 Liberty Boulevard
- City
- Malvern
- State
- PA
- Postal Code
- 19355
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2015-06-26 |
Proprietary Names
syngo.MI Workplace
syngo.via MI Taskflows
syngo.MI Cardiology (VB10, VB10A)
syngo.MI Reading (VB10, VB10A) (aka syngo.SPECT Reading and / or syngo.NM Reading)
syngo.via MI Workflows VB10A
syngo.MI Neurology (VB10, VB10A)
syngo.PET&CT Oncology (VB10, VB10A) (aka syngo.MM Oncology (VB10, VB10A))
Establishment Types
Manufacture Medical Device