FDA device listing
1.5T 8Ch GEM Breast Coil,1.5T HD Breast Array,1.5T HD Flat GEM Table Breast Array,Lateral Large Grid Biopsy…
FDA device listing 1609665491 · GE HealthCare Technologies Inc.
Key facts
| Proprietary names | 1.5T 8Ch GEM Breast Coil,1.5T HD Breast Array,1.5T HD Flat GEM Table Breast Array,Lateral Large Grid Biopsy Plate,liberty 9000 8-ch breast coil with disposable biopsy plate,Medial Large Grid Breast Biopsy Plate |
|---|---|
| Owner/operator | GE HealthCare Technologies Inc. |
| Owner/operator number | 9912004 |
| Premarket submissions | K041695 |
| 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 Coils, WIPRO GE HEALTHCARE PRIVATE LTD |
| Establishment registrations | 1529041, 9613936 |
| FEI numbers | 1000571342, 3005214683 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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