H4D Sas

H4D Sas specializes in the Consult Station TS, a medical device designed for clinical consultations and diagnostic support. It combines imaging and communication tools to enable remote or in-person interactions between healthcare providers, streamlining diagnostic workflows in medical settings.

H4D Sas is headquartered in the United States. The company’s location ensures compliance with U.S. regulatory standards, including those governing medical device development and distribution.

The Consult Station TS is classified as a Class II device by the FDA. This classification is based on its intended use—facilitating diagnostic consultations—which requires a balance of moderate risk mitigation through design controls and performance testing, as outlined in the 510(k) pathway.

The Consult Station TS is listed in the FDA’s 510(k) registry. This pathway demonstrates that the device meets FDA requirements for safety and effectiveness through pre-market notification, ensuring transparency for healthcare providers and regulators.

The 510(k) pathway is relevant because it confirms that the Consult Station TS is substantially equivalent to a legally marketed predicate device. This pathway is used for moderate-risk (Class II) devices like H4D Sas’s, where the company submits data proving the new device’s safety and performance aligns with existing, approved solutions.