FDA device listing
G3 RAD Elevation Table,GCTBL-C4,GT1700V (GT1700V N9 ED3, GT1700V),GT1700V(GT1700V N9 ED3, GT1700V),Kunlun Table,Lite…
FDA device listing 1303950144 · GE HealthCare Technologies Inc.
Key facts
| Proprietary names | G3 RAD Elevation Table,GCTBL-C4,GT1700V (GT1700V N9 ED3, GT1700V),GT1700V(GT1700V N9 ED3, GT1700V),Kunlun Table,Lite (LITE TABLE N9 ED3, Lite Table),NG1700 ELITE STANDARD TABLE,NG1700 Patient Table,NG1700SV Table,NG1700SV TABLE,NG2000 ELITE HEAVY TABLE,NG2000SV Table,NG2000SV TABLE,NG 2000 Table,NG2000V table,NG LITE 1700 (NG1700 ELITE STANDARD TABLE),NG LITE 2000 (NG2000 ELITE HEAVY TABLE),NM/CT… |
|---|---|
| Owner/operator | GE HealthCare Technologies Inc. |
| Owner/operator number | 9912004 |
| Product codes | IZZ |
| Device names | IZZ - Table, Radiographic, Non-Tilting, Powered |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1980 |
| Review panels | Radiology |
| Registered establishments | GE HANGWEI MEDICAL SYSTEMS CO., LTD., GE Healthcare (China) Co., Ltd., GE Healthcare Japan Corporation, GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING, GE MEDICAL SYSTEMS MONTERREY MEXICO, S.A. DE C.V., WIPRO GE MEDICAL DEVICE MANUFACTURING PRIVATE LIMITED |
| Establishment registrations | 9612283, 9613299, 9613445, 9616047, 3008284470, 3027338963, 3032109181 |
| FEI numbers | 3002175190, 3002808529, 3003377038, 3004571294, 3008284470, 3027338963, 3032109181 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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