Radical Imaging, LLC

Radical Imaging, LLC specializes in radiology DICOM image processing application software. Their products are designed to enhance diagnostic imaging workflows by improving visualization and analysis of medical images. For example, they offer tools like *FlexView Diagnostic* and its updated version (*FlexView Diagnostic v1.1.20*), which are tailored for radiologists and clinicians to refine image interpretation and efficiency.

Radical Imaging, LLC is headquartered in the United States. Their devices are regulated under U.S. FDA guidelines, specifically as Class II medical devices. Since the company operates within the U.S., its products fall under the jurisdiction of the FDA’s regulatory framework, including listings in the 510(k) and UDI databases.

Radical Imaging’s devices are included in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries track authorized medical devices in the U.S., ensuring transparency for healthcare providers, regulators, and stakeholders. The inclusion in these databases reflects compliance with FDA requirements for Class II devices.

Radical Imaging’s devices are classified as Class II medical devices by the FDA. This classification applies to products that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. Class II devices undergo a 510(k) premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device, ensuring they meet regulatory standards before commercialization.