Electronic Business Machine Co., Ltd. (Ebm)
Country not established
- Devices
- 3
What Electronic Business Machine Co., Ltd. (Ebm) makes
Electronic Business Machine Co., Ltd. manufactures medical imaging software and systems, including the UNIWEB version 5.0 for radiology workflow management, the UNISIGHT system with UNIGATE for integrated imaging and diagnostic viewing, and the UNISIGHT Mammography Viewer model 4.0 for digital mammography analysis.
The company’s portfolio consists of Class II devices, all of which are listed via the FDA’s 510(k) pathway. These products are regulated under US jurisdiction and are not included in any other major international registries.
Catalogue
Uniweb, Version 5.0 Ref K071166
Regimes: 510(k) Registry: 510(k)Unisight System With Unigate Ref K023394
Regimes: 510(k) Registry: 510(k)Unisight Mammography Viewer, Model 4.0 Ref K062743
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Electronic Business Machine Co., Ltd. (Ebm) have in the registry?
The registry currently lists 3 devices for Electronic Business Machine Co., Ltd. (Ebm). Devices recorded under merged duplicate company entries are counted once.
Which registries list Electronic Business Machine Co., Ltd. (Ebm)'s devices?
Among its 3 most recently registered devices, Electronic Business Machine Co., Ltd. (Ebm) has devices listed in FDA 510(k) (3 devices).
What risk classes do Electronic Business Machine Co., Ltd. (Ebm)'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Electronic Business Machine Co., Ltd. (Ebm)'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Electronic Business Machine Co., Ltd. (Ebm) in the registry?
The most recently registered devices listed for Electronic Business Machine Co., Ltd. (Ebm) include UNIWEB, VERSION 5.0, UNISIGHT SYSTEM WITH UNIGATE and UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0.