3DR Labs Announces FDA Clearance of NeuroDR, a First-of-Its-Kind Neurovascular Imaging AI with Zero-Click Autonomous 3D Anatomical Modeling
3DR Labs and Deep Reasoning AI Inc. announce 510(k) clearance from the U.S. Food and Drug Administration for NeuroDR. NeuroDR is a first-of-its-kind, fully automated, AI-driven Software as a Medical Device (SaMD) designed for high-precision neurovascular 3D segmentation, anatomical modeling, and vessel centerlining.
FDA 510(k) clearance number K262134