Intra-articular clarity. Cleared for your practice.

VisionScope® Technologies has received FDA 510(k) clearance to market the VisionScope system in the United States. The company also holds EN ISO 13485 quality system certification, a CE mark for the European Union market and ISO 13485 under CMDCAS for Canada.

 

Indications for Use

The VisionScope High Definition Endoscopy Camera System is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination, visualization and the capture of still and motion pictures of an interior cavity of the body through a natural or surgical opening. Examples of generic surgical use include imaging of articular cavities, body cavities, hollow organs and canals.

Additionally, when used in conjunction with an appropriately indicated and FDA 510(k)-cleared endoscope and light source, the VisionScope High Definition Endoscopy Camera Control Unit and Camera Handpiece are indicated for use in arthroscopic and endoscopic surgical procedures to provide illumination, visualization and the capture of still and motion pictures of articular cavities, body cavities, hollow organs and canals.