3D Line Medical Systems S.r.l.
Country not established
- Devices
- 2
What 3D Line Medical Systems S.r.l. makes
3D Line Medical Systems S.R.L. manufactures the ARGO system, a medical imaging device designed for intraoperative navigation and guidance, and the ERGO++ (Version 1.7), a surgical planning and tracking platform for orthopedic and spinal procedures. These tools integrate real-time imaging and robotic assistance to support precision surgical interventions.
The company’s portfolio is classified under FDA’s Class II regulatory category and is listed via the 510(k) premarket notification process. The devices are authorised for use in the United States, where the manufacturer is based.
Catalogue
Argos Ref K061479
Regimes: 510(k) Registry: 510(k)Ergo++ Version 1.7 Ref K080601
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does 3D Line Medical Systems S.R.L. have in the registry?
The registry currently lists 2 devices for 3D Line Medical Systems S.R.L.. Devices recorded under merged duplicate company entries are counted once.
Which registries list 3D Line Medical Systems S.R.L.'s devices?
Among its 2 most recently registered devices, 3D Line Medical Systems S.R.L. has devices listed in FDA 510(k) (2 devices).
What risk classes do 3D Line Medical Systems S.R.L.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for 3D Line Medical Systems S.R.L.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from 3D Line Medical Systems S.R.L. in the registry?
The most recently registered devices listed for 3D Line Medical Systems S.R.L. include ARGOS and ERGO++ VERSION 1.7.