Bay X-Ray, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Bay X-Ray, Inc. makes
Bay X-Ray, Inc. manufactures portable and fixed X-ray systems, including the HIMOBILIX 2N mobile imaging unit, the CATAPULT BUCKY and KATAPULT BLENDA grid devices, and X-ray tables like the TELESTATIX and RASTIX. Their portfolio also includes the UNDISTAT with EXPLORATOR 35 (UCS 35E) and the SELDIX 325 two-pulse generator/control unit, designed for radiographic imaging applications.
These devices are classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) database. The company operates from the United States, where its products are subject to U.S. medical device regulations.
Catalogue
Himobilix 2N Ref K883161
Regimes: 510(k) Registry: 510(k)Catapult Bucky (Katapult Blenda) Ref K883160
Regimes: 510(k) Registry: 510(k)Telestatix X-Ray Table Ref K883162
Regimes: 510(k) Registry: 510(k)Undistat With Explorator 35 (Ucs 35E) Ref K883153
Regimes: 510(k) Registry: 510(k)Rastix X-Ray Table Ref K883155
Regimes: 510(k) Registry: 510(k)Seldix 325 Two Pulse Generator/Control Ref K883154
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bay X-Ray, Inc. have in the registry?
The registry currently lists 6 devices for Bay X-Ray, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bay X-Ray, Inc.'s devices?
Among its 6 most recently registered devices, Bay X-Ray, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Bay X-Ray, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Bay X-Ray, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bay X-Ray, Inc. in the registry?
The most recently registered devices listed for Bay X-Ray, Inc. include HIMOBILIX 2N, CATAPULT BUCKY (KATAPULT BLENDA), TELESTATIX X-RAY TABLE and UNDISTAT WITH EXPLORATOR 35 (UCS 35E).