Howtek, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Howtek, Inc. makes
Howtek, Inc. manufactures medical imaging hardware and software, including the Howtek 960, Scanmaster DX, and Fulcrum scanners. The company also produces the Digitizer Director and its associated image compression module.
These devices are categorized as Class I and Class II medical devices and are listed within the FDA 510(k) regulatory registry. The company is based in the United States.
Catalogue
Howtek 960 Ref K970908
Regimes: 510(k) Registry: 510(k)Digitizer Director (HSC025-01) Ref K972191
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Scanmaster Dx Ref K953117
Regimes: 510(k) Registry: 510(k)Fulcrum Ref K021949
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Howtek, Inc. have in the registry?
The registry currently lists 5 devices for Howtek, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Howtek, Inc.'s devices?
Among its 5 most recently registered devices, Howtek, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Howtek, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Howtek, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Howtek, Inc. in the registry?
The most recently registered devices listed for Howtek, Inc. include HOWTEK 960, DIGITIZER DIRECTOR (HSC025-01), DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0) and SCANMASTER DX.