Hectec GmbH
GermanyFDA applicant, unverified
- Devices
- 1
What Hectec GmbH makes
Hectec GmbH manufactures the MEDICAD CLASSIC, a medical device designed for diagnostic imaging, specifically for mammography and breast cancer screening.
The MEDICAD CLASSIC is classified as a Class II device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Medicad Classic Ref K140434
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hectec GmbH have in the registry?
The registry currently lists 1 device for Hectec GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hectec GmbH's devices?
Among its 1 most recently registered device, Hectec GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Hectec GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Hectec GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hectec GmbH in the registry?
The most recently registered devices listed for Hectec GmbH include MEDICAD CLASSIC.