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HSA · registration DE0510316

Philips UroNav

SingaporeGeneral HospitalClass BPhilips DS North America LLC
Official record identity
Registration number
DE0510316
Model name
UroNav
Model identifier
784039
Registration date
February 07, 2025
Source update date
February 12, 2026
Classification
Risk class
Class B
Official value: CLASS B
Published category
General Hospital
Published parties
Registrant / registration holder
PHILIPS ELECTRONICS SINGAPORE PTE LTD
Official description

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.

Additional source fields
Product owner address
3630 SW 47th Avenue, Gainesville, Florida 32608, United States
Registrant address
622 LORONG 1 TOA PAYOH, Singapore 319763
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.