FDA device listing
2020 GE Optima XR240 Gen 2 ANZ 1,2020 GE Optima XR240 Gen 2 ANZ 2
FDA device listing 1170027189 · Medical Resale PTY Limited
Key facts
| Proprietary names | 2020 GE Optima XR240 Gen 2 ANZ 1,2020 GE Optima XR240 Gen 2 ANZ 2 |
|---|---|
| Owner/operator | Medical Resale PTY Limited |
| Owner/operator number | 10047901 |
| Premarket submissions | K182234 |
| Product codes | IZL, MQB |
| Device names | IZL - System, X-Ray, Mobile, MQB - Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1680, 892.1720 |
| Review panels | Radiology |
| Registered establishments | Medical Resale PTY Limited |
| Establishment registrations | 3011416394 |
| FEI numbers | 3011416394 |
| Establishment operations | Foreign Exporter |
| 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