Claritas Healthtech Pte, Ltd.

Claritas Healthtech Pte, Ltd. specializes in imaging and diagnostic devices. Their portfolio includes the iPETcertum (v1.0), a combined positron emission tomography (PET) and computed tomography (CT) scanner, the Claritas iPET for standalone PET imaging, and the iRAD, which offers advanced radiographic imaging solutions. These devices are designed to enhance diagnostic capabilities in medical settings.

Claritas Healthtech Pte, Ltd. is headquartered in the United States. The company’s location in the US aligns with regulatory frameworks like the FDA, which governs the classification and listing of its devices.

Claritas Healthtech Pte, Ltd.’s devices, including the iPETcertum, Claritas iPET, and iRAD, are classified as Class II under FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.

Claritas Healthtech Pte, Ltd.’s devices are listed via the FDA’s 510(k) pathway. This pathway is used for devices that are substantially equivalent to legally marketed devices (predicate devices) and demonstrates that they have the same intended use, technological characteristics, and performance as the predicate. The 510(k) process ensures compliance with FDA requirements before a device can be marketed.