Infomed Software, S.L.
SpainFDA applicant, unverified
- Devices
- 1
What Infomed Software, S.L. makes
Infomed Software, S.L. develops IMAGE ONE, a medical imaging software system designed for diagnostic radiology workflows, including image acquisition, display, and post-processing for radiologists.
The company’s portfolio is regulated under FDA 510(k) clearance as Class II devices and is listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Image One Ref K250716
Regimes: CE MDR 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Infomed Software, S.L. have in the registry?
The registry currently lists 1 device for Infomed Software, S.L.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Infomed Software, S.L.'s devices?
Among its 1 most recently registered device, Infomed Software, S.L. has devices listed in FDA 510(k) (1 device).
What risk classes do Infomed Software, S.L.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Infomed Software, S.L.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Infomed Software, S.L. in the registry?
The most recently registered devices listed for Infomed Software, S.L. include IMAGE ONE.