FDA device listing
Optima XR646 HD,Optima XR646 HD Upgrade
FDA device listing 1467931330 · GE HealthCare Technologies Inc.
Key facts
| Proprietary names | Optima XR646 HD,Optima XR646 HD Upgrade |
|---|---|
| Owner/operator | GE HealthCare Technologies Inc. |
| Owner/operator number | 9912004 |
| Premarket submissions | K173612 |
| Product codes | KPR, MQB |
| Device names | KPR - System, X-Ray, Stationary, MQB - Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1680 |
| Review panels | Radiology |
| Registered establishments | GE HANGWEI MEDICAL SYSTEMS CO., LTD., GE Healthcare (China) Co., Ltd. |
| Establishment registrations | 9613445, 3008284470 |
| FEI numbers | 3002175190, 3008284470 |
| 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
- 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