VARIOUS INSTRUMENTS FOR UROLOGY - OTHER

Primary DI

08885014610351

Basic UDI-DI Code

B-08885014610351

Reference

iSR'obot Mona Lisa

Device Types

None provided

Regulation

Eu Mdd

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Biobot Surgical Pte Ltd

The iSR’obot Mona Lisa is able to display the 2D live image feeds from commercially available ultrasound systems and also construct 3D ultrasound image stacks. The system allows the importation of an MRI image to create a model of patient prostate by providing fusion between Ultrasound and Magnetic Resonance Imaging (MRI). The system is compatible with commercially available ultrasound systems, transrectal ultrasound bi-plane probes, and commercially available needle devices. Other software features include multi-planar reconstruction, segmentation, image measurements and 2D/3D image registration. The device is a user-controlled, stereotaxic accessory intended to guide the urologist or physician in the planning and positioning of a needle during ultrasound-guided transperineal prostate procedures such as biopsies in the operating room. The iSR’obot Mona Lisa comprises of a workstation, robotic navigation module (comprising of robotic arm and stabilizer) and disposables.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).