Scanditronix, Inc.
Country not established
- Devices
- 7
What Scanditronix, Inc. makes
Scanditronix, Inc. manufactures diagnostic ultrasound devices, including the DIOLASE for imaging and the MM-22 MICROTRON and MM50 MICROTRON for medical imaging applications. The company also produces radiofrequency ablation equipment like the RFA A-300, therapeutic radiation dosimeters (DPD-3 and DPD-510), and a planning software tool, SCANDIPLAN (Version 338). Additionally, it offers the SUPERPETT, a device for medical imaging or diagnostic purposes.
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) database. Scanditronix, Inc. is based in the United States.
Catalogue
Diolase Ref K904753
Regimes: 510(k) Registry: 510(k)Mm-22 Microtron, MM50 Microtron Ref K900434
Regimes: 510(k) Registry: 510(k)Rfa A-300 Ref K934303
Regimes: 510(k) Registry: 510(k)Superpett Ref K843366
Regimes: 510(k) Registry: 510(k)Dpd-3 Ref K942092
Regimes: 510(k) Registry: 510(k)Dpd-510 Therapeutic Radiation Dosimeter Ref K925133
Regimes: 510(k) Registry: 510(k)Scandiplan - Version 338 Ref K914926
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Scanditronix, Inc. have in the registry?
The registry currently lists 7 devices for Scanditronix, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Scanditronix, Inc.'s devices?
Among its 7 most recently registered devices, Scanditronix, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Scanditronix, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Scanditronix, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Scanditronix, Inc. in the registry?
The most recently registered devices listed for Scanditronix, Inc. include DIOLASE, MM-22 MICROTRON, MM50 MICROTRON, RFA A-300 and SUPERPETT.