Hofmann X-Ray of America, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Hofmann X-Ray of America, Inc. makes
Hofmann X-Ray of America, Inc. manufactures single-phase X-ray generators, including the G-S60 model, and Potter-Bucky grids designed for radiographic imaging. Their product line includes the ESO5-110 and ESO5-220 series of Potter-Bucky devices, which are used to improve image clarity in X-ray procedures.
The company’s devices are classified under FDA categories Class I and Class II, with relevant products listed via the 510(k) pathway. These products are regulated under US medical device laws and are intended for commercial distribution within the United States.
Catalogue
Hofmann G-S60 Single Phase X-Ray Generator Ref K851011
Regimes: 510(k) Registry: 510(k)Super Speed Potter-Bucky (ESO5-110 & 220) Ref K893690
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hofmann X-Ray of America, Inc. have in the registry?
The registry currently lists 2 devices for Hofmann X-Ray of America, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hofmann X-Ray of America, Inc.'s devices?
Among its 2 most recently registered devices, Hofmann X-Ray of America, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Hofmann X-Ray of America, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Hofmann X-Ray of America, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hofmann X-Ray of America, Inc. in the registry?
The most recently registered devices listed for Hofmann X-Ray of America, Inc. include HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR and SUPER SPEED POTTER-BUCKY (ESO5-110 & 220).