FDA device listing
Discovery MR450,Discovery MR450 1.5T,Discovery MR750 3.0T,Discovery MR750w 3.0T,Optima MR450w 1.5T,SIGNA Architect,SIGNA…
FDA device listing 1503528666 · GE HealthCare Technologies Inc.
Key facts
| Proprietary names | Discovery MR450,Discovery MR450 1.5T,Discovery MR750 3.0T,Discovery MR750w 3.0T,Optima MR450w 1.5T,SIGNA Architect,SIGNA Artist |
|---|---|
| Owner/operator | GE HealthCare Technologies Inc. |
| Owner/operator number | 9912004 |
| Premarket submissions | K160618 |
| 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. |
| Establishment registrations | 2183553, 9616047, 3005326970, 3010949642, 3015329423 |
| FEI numbers | 2183553, 3003377038, 3005326970, 3010949642, 3015329423 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 10–99 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