Fona S.r.l.
ItalyFDA applicant, unverified
- Devices
- 4
What Fona S.r.l. makes
Fona S.R.L manufactures ultrasound imaging systems, including 2D and 3D transceivers (Stellaris series) and cephalic (Ceph) variants for specific anatomical imaging. Their portfolio also includes ultrasound probes (FONA Pan/Ceph and FONA XDC) and portable ultrasound devices (StarX series). These devices are designed for diagnostic imaging in medical settings.
The company’s products are classified as Class II medical devices under FDA regulations, with each model authorised via the 510(k) clearance process. The devices are listed in the FDA’s 510(k) database. Fona S.R.L operates from the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
FONA Pan/Ceph Ref K161131
Regimes: 510(k) Registry: 510(k)Fona Xdc Ref K222274
Regimes: 510(k) Registry: 510(k)StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 Ref K212103
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Fona S.R.L have in the registry?
The registry currently lists 4 devices for Fona S.R.L. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fona S.R.L's devices?
Among its 4 most recently registered devices, Fona S.R.L has devices listed in FDA 510(k) (4 devices).
What risk classes do Fona S.R.L's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Fona S.R.L's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Fona S.R.L in the registry?
The most recently registered devices listed for Fona S.R.L include Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph, FONA Pan/Ceph, FONA XDC and StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2.