FDA device listing
Optima MR450w,Optima MR450w GEM,Optima MR450w GEM XP Gradient
FDA device listing 1196014947 · GE HealthCare Technologies Inc.
Key facts
| Proprietary names | Optima MR450w,Optima MR450w GEM,Optima MR450w GEM XP Gradient |
|---|---|
| Owner/operator | GE HealthCare Technologies Inc. |
| Owner/operator number | 9912004 |
| Premarket submissions | K113490 |
| Product codes | LNH |
| Device names | LNH - System, Nuclear Magnetic Resonance Imaging |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1000 |
| Review panels | Radiology |
| Registered establishments | GE Healthcare Manufacturing LLC, GE HEALTHCARE (TIANJIN) COMPANY LIMITED, GE MEDICAL SYSTEMS, LLC, GE MEDICAL SYSTEMS MONTERREY MEXICO, S.A. DE C.V., WIPRO GE HEALTHCARE PRIVATE LTD |
| Establishment registrations | 2183553, 9613936, 9616047, 3005326970, 3010949642, 3015329423 |
| FEI numbers | 2183553, 1000571342, 3003377038, 3005326970, 3010949642, 3015329423 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database