Agfa-Gevaert, Inc.
Country not established
- Devices
- 4
What Agfa-Gevaert, Inc. makes
Agfa-Gevaert, Inc. manufactures medical imaging equipment, including the SCOPIX Video Imager for real-time fluoroscopy, mammography systems with cassettes for breast imaging, and the CURIX Capacity Film Center for processing and handling radiographic film.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) clearance process. The company operates from the United States.
Catalogue
Adc Compact Plus Ref K013138
Regimes: 510(k) Registry: 510(k)Scopix Video Imager Ref K882096
Regimes: 510(k) Registry: 510(k)Mammography System And Cassette Ref K790273
Regimes: 510(k) Registry: 510(k)Curix Capacity Film Center Ref K832603
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Agfa-Gevaert, Inc. have in the registry?
The registry currently lists 4 devices for Agfa-Gevaert, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Agfa-Gevaert, Inc.'s devices?
Among its 4 most recently registered devices, Agfa-Gevaert, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Agfa-Gevaert, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Agfa-Gevaert, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Agfa-Gevaert, Inc. in the registry?
The most recently registered devices listed for Agfa-Gevaert, Inc. include ADC COMPACT PLUS, SCOPIX VIDEO IMAGER, MAMMOGRAPHY SYSTEM AND CASSETTE and CURIX CAPACITY FILM CENTER.