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
System, Nuclear Magnetic Resonance Imaging LNH

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