Digestaid - Artificial Intelligence Development SA
PortugalFDA applicant, unverified
- Devices
- 1
What Digestaid - Artificial Intelligence Development SA makes
Digestaid develops the Deep Capsule®, a wireless capsule designed for diagnostic imaging of the gastrointestinal tract to detect abnormalities such as tumors, ulcers, or inflammation.
The Deep Capsule® is classified as a Class II medical device in the US and is authorised through the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Deep Capsule® (Deep Capsule US) Ref K250655
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Digestaid - Artificial Intelligence Development SA have in the registry?
The registry currently lists 1 device for Digestaid - Artificial Intelligence Development SA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Digestaid - Artificial Intelligence Development SA's devices?
Among its 1 most recently registered device, Digestaid - Artificial Intelligence Development SA has devices listed in FDA 510(k) (1 device).
What risk classes do Digestaid - Artificial Intelligence Development SA's devices fall under?
Among its 1 most recently registered device, the classes recorded for Digestaid - Artificial Intelligence Development SA's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Digestaid - Artificial Intelligence Development SA in the registry?
The most recently registered devices listed for Digestaid - Artificial Intelligence Development SA include Deep Capsule® (Deep Capsule US).