Philips UroNav - HSA Registration DE0510316
Access comprehensive regulatory information for Philips UroNav in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510316 and owned by Philips DS North America LLC. The device was registered on February 07, 2025.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
UroNav is a stereotaxic medical device intended to assist the clinician with planning and guidance for clinical, interventional and/or diagnostic procedures for biopsy and/or soft tissue ablation. It provides 2D and 3D visualization of Ultrasound images and the ability to fuse and register these images with those from other imaging modalities such as Magnetic Resonance. It is also able to display a simulated image of a tracked insertion tool such as a biopsy needle, guidewire, grid plate or probe on a computer monitor screen that shows images of the target organ and the current and projected future path of the interventional instrument taking into account patient movement. Other software features include patient data management, multiplanar reconstruction, segmentation, image measurements and 2D/3D image registration. It is indicated for medical conditions that require interventional and/or diagnostic procedures of the prostate gland. The software is not intended for diagnosis.