FDA device listing
3DXR,Allia IGS 3,Allia IGS 5,Allia IGS 7,Allia IGS 7 OR,Cardiac X-ray Analysis,Discovery IGS 7,Discovery IGS 7 OR,IGS WF…
FDA device listing 1774487428 · GE HealthCare Technologies Inc.
Key facts
| Proprietary names | 3DXR,Allia IGS 3,Allia IGS 5,Allia IGS 7,Allia IGS 7 OR,Cardiac X-ray Analysis,Discovery IGS 7,Discovery IGS 7 OR,IGS WF BP,IGS WF SP,Innova IGS 3,Innova IGS 5,Innova IGS 6,Optima IGS Mega,Optima IGS Ultra |
|---|---|
| Owner/operator | GE HealthCare Technologies Inc. |
| Owner/operator number | 9912004 |
| Premarket submissions | K181403 |
| Product codes | IZI, JAA, OWB, OXO |
| Device names | IZI - System, X-Ray, Angiographic, JAA - System, X-Ray, Fluoroscopic, Image-Intensified, OWB - Interventional Fluoroscopic X-Ray System, OXO - Image-Intensified Fluoroscopic X-Ray System, Mobile |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1600, 892.1650 |
| Review panels | Radiology |
| Registered establishments | GE HANGWEI MEDICAL SYSTEMS CO., LTD., GE Healthcare (China) Co., Ltd., GE MEDICAL SYSTEMS SCS |
| Establishment registrations | 9611343, 9613445, 3008284470 |
| FEI numbers | 1000284313, 3002175190, 3008284470 |
| 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