EXPLORER AIR II

GUDID 04260721460002

EXPLORER AIR® II consists of an imaging system that contains two cameras (one (1) for fluorescence, one (1) for color images) suspended by an articulated arm attached to a trolley. A touch screen and secondary monitor are also mounted on the trolley. EXPLORER AIR® II enhances the surgeon’s vision with use of near infrared fluorescence (NIR) imaging. The technology is based on the exposure of the tissue of interest to light after fluorescent dye such as indocyanine green (ICG) or pafolacianine has been administered to the patient. The EXPLORER AIR® II visualizes fluorescence excited by infrared light (740-760nm) and emitted in the band around 800nm. After image acquisition, the composite image (overlay of fluorescence and color images) is displayed along with the fluorescent and color images. The user can tag and compare images, play the recorded videos, and export the selected files. The EXPLORER AIR® II must be used with EXPLORER AIR® Sterile Drape for use under sterile conditions. The EXPLORER AIR® Sterile Drape is manufactured by Exact Medical Manufacturing, Inc., and has been cleared in K101689.

SurgVision GmbH

Customer Support Contacts

Device Identifiers

FDA Product Code

Sterilization

Device Entry Metadata