FDA Registration
Active
🇺🇸 United States
3T SPLIT HEAD COIL
Reg #: 1529041
·
FEI: 3005214683
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GE Healthcare Coils
- Registration Number
- 1529041
- FEI Number
- 3005214683
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1515 DANNER DR
- City
- AURORA
- State
- OH
- ZIP
- 44202
- Country
- US
Regulatory Submissions
- 510(k) Number
- K013636
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 Imaging | LNH | Class 2 | Radiology | No | 2010-07-16 |
Proprietary Names
3T SPLIT HEAD COIL
1.5T SPLIT HEAD COIL
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY
Signa Excite 1.5T Expert.
3" ROUND COIL 1.5T
5" ROUND COIL 1.5T
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility