Bayer Corp., Agfa Div.
United StatesFDA applicant, unverified
- Devices
- 3
What Bayer Corp., Agfa Div. makes
The company manufactures medical imaging devices, including computed radiography (CR) systems like the CP 1000, CURIX HT 330, and MAMORAY HT 300, as well as digital X-ray detectors such as the CLASSIC E.O.S. and CURIX COMPACT PLUS. It also produces film-based laser film recorders, including the LR 5200, and diagnostic imaging centers like the ADC COMPACT. These products are designed for radiography and diagnostic imaging workflows.
The portfolio consists of Class II medical devices, all of which are listed under the FDA’s 510(k) pathway. The company’s products are registered in the U.S. regulatory system, adhering to FDA requirements for imaging equipment. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Adc Compact (Agfa Diagnostic Center) Ref K974597
Regimes: 510(k) Registry: 510(k)Lr 5200 Laser Film Recorder Ref K964414
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bayer Corp., Agfa Div. have in the registry?
The registry currently lists 3 devices for Bayer Corp., Agfa Div.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bayer Corp., Agfa Div.'s devices?
Among its 3 most recently registered devices, Bayer Corp., Agfa Div. has devices listed in FDA 510(k) (3 devices).
What risk classes do Bayer Corp., Agfa Div.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Bayer Corp., Agfa Div.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bayer Corp., Agfa Div. in the registry?
The most recently registered devices listed for Bayer Corp., Agfa Div. include CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS, ADC COMPACT (AGFA DIAGNOSTIC CENTER) and LR 5200 LASER FILM RECORDER.