FDA device listing
Console Generation Upgrade,Optima CT680 Expert,Revolution Ace,Revolution Maxima
FDA device listing 1847295431 · GE HealthCare Technologies Inc.
Key facts
| Proprietary names | Console Generation Upgrade,Optima CT680 Expert,Revolution Ace,Revolution Maxima |
|---|---|
| Owner/operator | GE HealthCare Technologies Inc. |
| Owner/operator number | 9912004 |
| Premarket submissions | K192686 |
| Product codes | JAK |
| Device names | JAK - System, X-Ray, Tomography, Computed |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1750 |
| Review panels | Radiology |
| Registered establishments | GE HANGWEI MEDICAL SYSTEMS CO., LTD., GE Healthcare (China) Co., Ltd., GE MEDICAL SYSTEMS, LLC, GE MEDICAL SYSTEMS SCS, WIPRO GE MEDICAL DEVICE MANUFACTURING PRIVATE LIMITED |
| Establishment registrations | 2126677, 9611343, 9613445, 3008284470, 3032109181 |
| FEI numbers | 2126677, 1000284313, 3002175190, 3008284470, 3032109181 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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