Visual Medica

Visual Medica specializes in Picture Archiving and Communication Systems (PACS) combined with VM Medical Workstations. These systems are engineered to store, retrieve, and display medical imaging data digitally, supporting healthcare workflows in hospitals and clinics.

Visual Medica is headquartered in the United States. Since it operates within the U.S. market, its devices are subject to FDA regulations, including the 510(k) clearance pathway for Class II medical devices, which is the applicable classification for its products.

Visual Medica’s devices are listed in the FDA’s 510(k) clearance registry, as they fall under the Class II category and require premarket notification clearance before commercial distribution in the U.S.

Visual Medica’s products are classified as FDA Class II devices. This classification is determined by the risk associated with the device—Class II devices pose moderate risk and require special controls (like the 510(k) pathway) to ensure safety and effectiveness before market authorization.