FDA device listing
CareView 1800Le X-Ray Flat Panel Detectors,EXAMVue Duo EV17T
FDA device listing 1282752684 · CareRay Digital Medical Technology Co., Ltd.
Key facts
| Proprietary names | CareView 1800Le X-Ray Flat Panel Detectors,EXAMVue Duo EV17T |
|---|---|
| Owner/operator | CareRay Digital Medical Technology Co., Ltd. |
| Owner/operator number | 10050244 |
| Premarket submissions | K193173 |
| 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 | CARERAY DIGITAL MEDICAL TECHNOLOGY CO., LTD. |
| Establishment registrations | 3011158427 |
| FEI numbers | 3011158427 |
| Establishment operations | Manufacturer |
| 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