4Dmedical Limited

4Dmedical Limited specializes in CT system application software, specifically tools designed to analyze lung ventilation. Their products, such as the XV Lung Ventilation Analysis Software and CT Lung Ventilation Analysis Software (CT:V), integrate with CT imaging systems to provide quantitative assessments of lung function and ventilation distribution. These solutions are software-based and do not involve physical hardware.

4Dmedical Limited is based in the United States, which means its devices fall under the jurisdiction of the FDA (U.S. Food and Drug Administration). Since the company’s products are software applications for CT systems, they are classified under U.S. regulatory pathways like the 510(k) clearance process and the Unique Device Identifier (UDI) program, ensuring traceability and compliance with U.S. medical device regulations.

4Dmedical Limited’s devices are documented in FDA-specific registries, including the 510(k) clearance database (for premarket submissions) and the FDA’s Unique Device Identifier (UDI) system. These registries track device authorizations, compliance, and identification requirements, ensuring transparency in the medical device supply chain. The company’s products are not listed in general medical device directories but are formally recognized through these FDA pathways.

4Dmedical Limited’s CT system application software is classified as Class II devices under the U.S. FDA’s regulatory framework. This classification applies because the software modifies or enhances the performance of existing CT systems for diagnostic purposes, specifically lung ventilation analysis. Class II devices typically require special controls (such as performance standards or post-market surveillance) to ensure safety and effectiveness, which aligns with the company’s focus on quantitative medical imaging analysis.