Dexela, Ltd.
Country not established
- Devices
- 1
What Dexela, Ltd. makes
Dexela, Ltd. manufactures the DEXELA DEX TOP Mammography Workstation (Model MAMWKVI), a device designed for digital breast imaging and mammographic examinations. This workstation integrates imaging acquisition, processing, and display capabilities for diagnostic and screening purposes in radiology settings.
The DEX TOP Mammography Workstation is classified as a Class II medical device under FDA regulations and is listed via the 510(k) clearance process. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dexela, Ltd. have in the registry?
The registry currently lists 1 device for Dexela, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dexela, Ltd.'s devices?
Among its 1 most recently registered device, Dexela, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Dexela, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Dexela, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dexela, Ltd. in the registry?
The most recently registered devices listed for Dexela, Ltd. include DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI.