FDA device listing
EXPD 3643N,EXPD 3643N1,EXPD 3643NP,EXPD 3643NU,EXPD 3643U1,EXPD 4343N,EXPD 4343N1,EXPD 4343NP,EXPD 4343NU,EXPD 4343U1
FDA device listing 1802944247 · DRTECH CORPORATION
Key facts
| Proprietary names | EXPD 3643N,EXPD 3643N1,EXPD 3643NP,EXPD 3643NU,EXPD 3643U1,EXPD 4343N,EXPD 4343N1,EXPD 4343NP,EXPD 4343NU,EXPD 4343U1 |
|---|---|
| Owner/operator | DRTECH CORPORATION |
| Owner/operator number | 9073399 |
| Premarket submissions | K243443 |
| 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 | DRTECH Corporation |
| Establishment registrations | 3005172103 |
| FEI numbers | 3005172103 |
| Establishment operations | Manufacturer |
| 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