Clarix Imaging
Country not established
Clarix Imaging is a medical device manufacturer, with 2 devices listed in FDA 510(k) and FDA GUDID (FDA Class II) as of 15 Nov 2026.
- Devices
- 2
Registry facts
- Registries
- FDA 510(k) 1
- FDA GUDID 1
- Device classes
- FDA Class II 2
What Clarix Imaging makes
Clarix Imaging manufactures tissue specimen x-ray systems designed for in vitro diagnostic (IVD) use, including devices like the *Clarix Imaging Corps* and the *Volumetric Specimen Imager*. These systems are intended for imaging and analyzing tissue samples, aiding in pathology workflows.
The company’s products fall under FDA Class II regulatory classification and are listed via 510(k) clearance and UDI registration. The manufacturer operates from the United States, adhering to US regulatory requirements for medical imaging devices.
Catalogue
- Registry: GUDID
Volumetric Specimen Imager Ref K192939
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Clarix Imaging have in the registry?
The registry currently lists 2 devices for Clarix Imaging. Devices recorded under merged duplicate company entries are counted once.
Which registries list Clarix Imaging's devices?
Among its 2 most recently registered devices, Clarix Imaging has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Clarix Imaging's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Clarix Imaging's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Clarix Imaging in the registry?
The most recently registered devices listed for Clarix Imaging include Clarix Imaging Corps VSI-1 and Volumetric Specimen Imager.