Swissray International, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Swissray International, Inc. makes
Swissray International, Inc. manufactures digital radiography systems, including portable trauma X-ray units (DDRCOMBI TRAUMA) and compact chest X-ray devices (DDRCOMPACT, DDRCOMPACT PLUS, DDRCOMPACT CHEST). The company also produces digital add-on systems for multi-system compatibility, designed for emergency and point-of-care imaging.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Catalogue
Ddrcombi Trauma Ref K050718
Regimes: 510(k) Registry: 510(k)Ddrcompact, Ddrcompact Plus And Ddrcompact Chest Ref K070678
Regimes: 510(k) Registry: 510(k)Digital Add On Multi System Ref K973710
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Swissray International, Inc. have in the registry?
The registry currently lists 3 devices for Swissray International, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Swissray International, Inc.'s devices?
Among its 3 most recently registered devices, Swissray International, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Swissray International, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Swissray International, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Swissray International, Inc. in the registry?
The most recently registered devices listed for Swissray International, Inc. include DDRCOMBI TRAUMA, DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST and DIGITAL ADD ON MULTI SYSTEM.