REALCLOUD IMAGING, INC.

RealCloud Imaging, Inc. specializes in dental and radiological imaging solutions. Their portfolio includes intraoral cameras, such as the RealCloud HD1, which capture detailed images inside the mouth for dental examinations. They also develop radiological Picture Archiving and Communication Systems (PACS) software and radiology information system applications, like Dentrix Smart Image and Dentrix Ascend Imaging, which help manage and organize medical imaging data.

RealCloud Imaging, Inc. is headquartered in the United States. The company’s location in the US aligns with regulatory frameworks like the FDA, which governs the authorization of its devices.

RealCloud Imaging, Inc.’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA Unique Device Identification (UDI) system. These registries track devices that have undergone the necessary authorization processes for Class I and Class II devices, ensuring compliance with US medical device regulations.

RealCloud Imaging, Inc.’s devices fall into two primary FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and may require less stringent regulatory controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The specific classification depends on the device’s intended use and potential risks, as outlined in the FDA’s regulatory framework.