FDA Registration
Active
🇺🇸 United States
SIGNA 7T
Reg #: 3005326970
·
FEI: 3005326970
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- GE Healthcare Manufacturing LLC
- Registration Number
- 3005326970
- FEI Number
- 3005326970
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3001 W RADIO DR
- City
- FLORENCE
- State
- SC
- ZIP
- 29501
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201615
Owner / Operator
- Firm Name
- GE HealthCare Technologies Inc.
- Operator Number
- 9912004
- Address
- 3000 N. Grandview Blvd
- City
- Waukesha
- State
- WI
- Postal Code
- 53188
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | Class 2 | Radiology | No | 2020-10-26 |
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2020-10-26 |
| Coil, Magnetic Resonance, Specialty | MOS | Class 2 | Radiology | No | 2020-10-26 |
Proprietary Names
SIGNA 7T
Establishment Types
Manufacture Medical Device