FDA Registration
Active
🇺🇸 United States
Discovery MR750 3T
Reg #: 3013679558
·
FEI: 3013679558
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Repair Operations Center
- Registration Number
- 3013679558
- FEI Number
- 3013679558
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 120 Opus Drive
- City
- Oak Creek
- State
- WI
- ZIP
- 53154
- Country
- US
Regulatory Submissions
- 510(k) Number
- K142085
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 | 2014-12-05 |
Proprietary Names
Discovery MR750 3T
Discovery MR450 1.5T
1.5T Split Head Coil
Optima MR 450w
Discovery MR450
3T SPLIT HEAD COIL
Discovery MR750w 3T
Optima MR450w 1.5T
Optima MR 450w GEM
GoldSeal MR450w GEM 30.1
Establishment Types
Remanufacture Medical Device