Clarix Imaging

Clarix Imaging specializes in tissue specimen x-ray systems classified as in vitro diagnostic (IVD) devices. These systems are designed to image and analyze tissue samples, supporting pathology workflows. Examples include the *Clarix Imaging Corps* and the *Volumetric Specimen Imager*, which are tailored for detailed specimen visualization.

Clarix Imaging is based in the United States, which means its devices must comply with FDA regulations. Since the company’s products fall under FDA Class II classification, they undergo review through the 510(k) clearance process and are registered via Unique Device Identification (UDI). This ensures alignment with US regulatory standards for medical imaging devices.

Clarix Imaging’s devices are listed in the FDA’s 510(k) clearance registry and the FDA’s Unique Device Identifier (UDI) database. These registries confirm the devices’ compliance with FDA requirements, including their classification as Class II medical devices. Listing in these databases is a standard step for devices intended for the US market.

Clarix Imaging’s tissue specimen x-ray systems are classified as FDA Class II devices. This classification is based on their intended use—imaging and analyzing tissue samples for diagnostic purposes—which requires a higher level of scrutiny than Class I but not the stringent premarket approval process of Class III. The 510(k) pathway is used to demonstrate substantial equivalence to existing predicate devices.