Matakina Technology Limited
New ZealandFDA applicant, unverified
- Devices
- 2
What Matakina Technology Limited makes
Matakina Technology Limited manufactures VOLPARA, Version 1.3, a medical imaging device designed for volumetric breast assessment and density analysis using mammographic data.
The device is classified as Class II under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Volpara Imaging Software Ref K153427
Regimes: 510(k) Registry: 510(k)Volpara, Version 1.3 Ref K102556
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Matakina Technology Limited have in the registry?
The registry currently lists 2 devices for Matakina Technology Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Matakina Technology Limited's devices?
Among its 2 most recently registered devices, Matakina Technology Limited has devices listed in FDA 510(k) (2 devices).
What risk classes do Matakina Technology Limited's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Matakina Technology Limited's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Matakina Technology Limited in the registry?
The most recently registered devices listed for Matakina Technology Limited include Volpara Imaging Software and VOLPARA, VERSION 1.3.