Futrex, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 4
What Futrex, Inc. makes
Futrex, Inc. manufactures Class II medical devices, including the FUTREX-6100/XL, HealthGuard-15, FUTREX-5000, and FUTREX-5000A. These products appear to be designed for diagnostic or monitoring purposes, likely within radiology or imaging applications, such as X-ray systems or related accessories.
The company’s portfolio is regulated under the FDA’s 510(k) pathway as Class II devices. These products are listed in the FDA’s 510(k) database, indicating they meet U.S. regulatory requirements for marketing. Futrex, Inc. is based in the United States.
Catalogue
Futrex-6100/Xl Ref K963271
510(k) 510(k)HealthGuard-15 Ref K143108
510(k) 510(k)Futrex-5000 Ref K922600
510(k) 510(k)Futrex-5000A Ref K922601
510(k) 510(k)
Frequently asked questions
How many devices does Futrex, Inc. have in the registry?
The registry currently lists 4 devices for Futrex, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Futrex, Inc.'s devices?
Among its 4 most recently registered devices, Futrex, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Futrex, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Futrex, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Futrex, Inc. in the registry?
The most recently registered devices listed for Futrex, Inc. include FUTREX-6100/XL, HealthGuard-15, FUTREX-5000 and FUTREX-5000A.