Artera, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Artera, Inc. makes
Artera, Inc. develops AI-powered ultrasound imaging systems, including the ArteraAI Breast and ArteraAI Prostate, designed for targeted tissue analysis and diagnostic support in breast and prostate evaluations.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
ArteraAI Breast Ref K254115
Regimes: 510(k) Registry: 510(k)ArteraAI Prostate Ref DEN240068
Regimes: De Novo Registry: 510(k)
Frequently asked questions
How many devices does Artera, Inc. have in the registry?
The registry currently lists 2 devices for Artera, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Artera, Inc.'s devices?
Among its 2 most recently registered devices, Artera, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Artera, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Artera, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Artera, Inc. in the registry?
The most recently registered devices listed for Artera, Inc. include ArteraAI Breast and ArteraAI Prostate.