Ortivus AB
SwedenFDA applicant, unverified
- Devices
- 1
What Ortivus AB makes
Ortivus AB develops the MIDA Algorithm Rev. B, a software-based medical device designed for diagnostic imaging analysis, specifically for identifying and quantifying bone mineral density and structural metrics in medical imaging studies.
The MIDA Algorithm Rev. B is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) registry. The company is based in the United States.
Catalogue
Mida Algorithm Rev. B Ref K023414
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ortivus AB have in the registry?
The registry currently lists 1 device for Ortivus AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ortivus AB's devices?
Among its 1 most recently registered device, Ortivus AB has devices listed in FDA 510(k) (1 device).
What risk classes do Ortivus AB's devices fall under?
Among its 1 most recently registered device, the classes recorded for Ortivus AB's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ortivus AB in the registry?
The most recently registered devices listed for Ortivus AB include MIDA ALGORITHM REV. B.