Digimed Corporation

Digimed Corporation specializes in portable diagnostic x-ray system generators. Their primary products include standalone portable x-ray systems like the XTG PRO 70 and MiniX-V, as well as handheld intraoral dental x-ray systems designed for digital imaging, such as the DIOX-602 and DHX-70H. These devices are engineered for flexibility and ease of use in clinical settings where mobility is essential.

Digimed Corporation is based in the United States. Since the company operates domestically, its devices must comply with U.S. regulatory requirements, including those outlined by the FDA. The regulatory classification and submission pathways, such as FDA 510(k) and UDI registries, reflect these domestic compliance standards.

Digimed Corporation’s devices are listed in the FDA 510(k) and FDA UDI registries. The 510(k) pathway is used for demonstrating substantial equivalence to a predicate device, while the UDI (Unique Device Identifier) registry ensures traceability and transparency in the supply chain. Both registries are critical for tracking and authorizing Class II medical devices in the U.S.

Digimed Corporation’s devices are classified as Class II under regulatory frameworks. This classification typically applies to devices that pose moderate risk and require special controls to ensure their safety and effectiveness. The classification influences the regulatory submission process, such as the need for a 510(k) premarket notification, to demonstrate compliance with applicable requirements.