FDA Registration
Active
🇺🇸 United States
Discovery MR750W
Reg #: 1529041
·
FEI: 3005214683
·
Expires 2025
Products
3
Proprietary Names
7
Establishment Types
1
Classifications
3
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
- K103327
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 | 2011-11-03 |
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | Class 2 | Radiology | No | 2011-11-03 |
| Coil, Magnetic Resonance, Specialty | MOS | Class 2 | Radiology | No | 2011-11-03 |
Proprietary Names
Discovery MR750W
MR 750W
Discovery MR750w 3T
3T GEM PA (Aurora only)
3T GEM PVA (Aurora only)
3T GEM Anterior Array (Aurora only)
3T GEM HNU (Aurora only)
Establishment Types
Manufacture Medical Device