FDA device listing
Luna1012X Wireless Digital Flat Panel Detector,Mano2530A Wireless Digital Flat Panel Detector,Mano2530F Wireless Digital…
FDA device listing 1910167771 · iRay Imaging Technology Taicang Limited
Key facts
| Proprietary names | Luna1012X Wireless Digital Flat Panel Detector,Mano2530A Wireless Digital Flat Panel Detector,Mano2530F Wireless Digital Flat Panel Detector |
|---|---|
| Owner/operator | iRay Imaging Technology Taicang Limited |
| Owner/operator number | 10058988 |
| Product codes | MQB |
| Device names | 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 | iRay Imaging Technology Taicang Limited |
| Establishment registrations | 3014544225 |
| FEI numbers | 3014544225 |
| Establishment operations | Contract Manufacturer |
| 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