Scolioscan

Primary DI

04897122680014

Basic UDI-DI Code

489712268SCN201JU

Reference

SCN201

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Telefield Medical Imaging Limited

Scolioscan Air – Portable Radiation-free 3D UltrasoundScoliosis Assessment System (model number:SCN201) is a new palm-sized ultrasound imagingsystem for scoliosis assessment. Scolioscan Airconsists of a handheld ultrasound module and atracking camera that are integrated with ergonomiccasing. The system is intended to be connected to aWindows based tablet or laptop by USB cable, runningwith a dedicated software. Scolioscan Air hasimplemented with 3D ultrasound imaging technique tobuild the 3D image of spine and with advanced volumeproject imaging technique to generate the coronalimage of spine, which is similar to the posterior-anteriorradiograph and is used to assess the spine deformity byidentifying different spinal bony landmarks. ScolioscanAir provides patient database management for ease ofoperation and follow up, and measurement tool forassessing the curvature or deformity of spine manuallyor automatically. Because of the use of radiation-freeultrasound imaging technique, the clinical application ofScolioscan Air poses a great clinical benefit for thepatient, especially children who are the major patientpopulation, comparing to the traditional golden clinicalexamination, X-ray, exposure to ionizing radiation.Scolioscan Air is safe without radiation, it is able to offerthe purpose of scoliosis screening & curve progressionmonitoring, which are not allowed with the use of X-raygenerally. Besides being radiation-free, the palm-sizeddesign allows scoliosis assessments to be conductednot only at hospitals, but also small clinics, schools and healthcare centers.

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