FDA device listing
CARESTREAM DRX-EVOLUTION PLUS,DR-FIT X-ray System,DRX-Compass X-ray System,Lux HD 35 Detector,Lux HD 43 Detector
FDA device listing 1259804588 · Carestream Health, Inc.
Key facts
| Proprietary names | CARESTREAM DRX-EVOLUTION PLUS,DR-FIT X-ray System,DRX-Compass X-ray System,Lux HD 35 Detector,Lux HD 43 Detector |
|---|---|
| Owner/operator | Carestream Health, Inc. |
| Owner/operator number | 9097221 |
| Premarket submissions | K250954 |
| 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 | Carestream Health, Inc, CARESTREAM HEALTH, INC., GLOBAL R&D CENTER |
| Establishment registrations | 1317307, 3005778458 |
| FEI numbers | 1317307, 3005778458 |
| Establishment operations | Manufacturer, Specification Developer |
| 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