Scanditronix Medical AB
Country not established
- Devices
- 4
What Scanditronix Medical AB makes
Scanditronix Medical AB manufactures medical imaging and radiation therapy devices, including the INVIDOS system for intraoperative imaging and the RFA-300 and LDA UTILITY for radiofrequency ablation and laser Doppler applications. The DPD-12PCC appears to be a dosimetry device for precise radiation measurement, while the OMNIDOS likely supports dosimetry planning or verification in radiotherapy workflows.
These devices are classified under Class II by the FDA and are listed via the 510(k) pathway. The company is based in the US, adhering to regulatory requirements for medical devices in that jurisdiction.
Catalogue
Invidos Ref K002051
Regimes: 510(k) Registry: 510(k)Rfa-300, Lda Utility Ref K961400
Regimes: 510(k) Registry: 510(k)Dpd-12PCC Ref K990734
Regimes: 510(k) Registry: 510(k)Omnidos Ref K011763
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Scanditronix Medical AB have in the registry?
The registry currently lists 4 devices for Scanditronix Medical AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Scanditronix Medical AB's devices?
Among its 4 most recently registered devices, Scanditronix Medical AB has devices listed in FDA 510(k) (4 devices).
What risk classes do Scanditronix Medical AB's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Scanditronix Medical AB's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Scanditronix Medical AB in the registry?
The most recently registered devices listed for Scanditronix Medical AB include INVIDOS, RFA-300, LDA UTILITY, DPD-12PCC and OMNIDOS.