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The device is intended for use in all types of endoscopic and endoscopic assisted procedures, including general thoracic and as an aid in visualization of the evacuated cardiac chamber.

The 3D Video Endoscope System is a device used to allow observation in body cavities, organs, or canals through manmade or natural orifices. It is designed for use in all types of endoscopic and endoscopic assisted procedures, including general thoracic and as an aid in visualization of the evacuated cardiac chamber. The product is an integrated endoscope and video camera. The system will be supplied as a 3D Video Endoscope and Camera Control Unit. The device is designed to work with commercially available light sources, and video monitors or head mounted displays (HMD). Additionally the device can be mounted in a rack and used as one module of a rack mounted system.

The device is intended for use in endoscopic procedures and all types of video assisted procedures, including anterior spinal and general thoracic procedures and as an aid in visualization of the evacuated cardiac chamber.

The Vista Mini Camera System is a device used to allow observation in body cavities, organs, or canals through manmade or natural orificies. It is designed for use in endoscopic procedures and all types of video assisted procedures, including anterior spinal and general thoracic procedures and as an aid in visualization of the evacuated cardiac chamber. The product is a video camera. The system will be supplied as a Vista Mini Camera, intended to be used with a Vista camera control unit (CCU). The device is designed to work with commercially available light sources and video monitors or head mounted displays.

The 3D SCOPE™ is designed to aid in visualization for general endoscopic and laparascopic procedures including general thoracic, and as an aid in visualization and examination of the evacuated cardiac chambers.

This 510(k) submission is for the addition of an indication for use of the currently marketed, cleared device 3D SCOPE™ Three Dimensional Medical Video System. 510(k) #: K923160. The primary application cleared for the AST 3D SCOPE™ is general endoscopic surgery and laproscopic procedures. This includes general thoracic procedures.