Alphatek Corp.
United StatesFDA applicant, unverified
- Devices
- 5
What Alphatek Corp. makes
Alphatek Corp. manufactures automatic X-ray film processors, including models such as the AX-300SE, MAMMO-300, AX-700LE, AX-390SE, and AX200. These devices are designed for processing radiographic film in medical imaging settings, ensuring proper development and fixation of exposed film.
The company’s portfolio consists of Class II medical devices, all of which are listed via the FDA’s 510(k) pathway. These devices are regulated under U.S. jurisdiction, with records maintained in the FDA’s 510(k) database.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Mammo-300 Automatic X-Ray Film Processor Ref K931882
Regimes: 510(k) Registry: 510(k)Ax-700LE Automatic X-Ray Film Processor Ref K925569
Regimes: 510(k) Registry: 510(k)Ax-390SE Automatic X-Ray Film Processor 9586.033 Ref K931883
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Alphatek Corp. have in the registry?
The registry currently lists 5 devices for Alphatek Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alphatek Corp.'s devices?
Among its 5 most recently registered devices, Alphatek Corp. has devices listed in FDA 510(k) (5 devices).
What risk classes do Alphatek Corp.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Alphatek Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Alphatek Corp. in the registry?
The most recently registered devices listed for Alphatek Corp. include AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027, MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR, AX-700LE AUTOMATIC X-RAY FILM PROCESSOR and AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033.