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510(k) Data Aggregation
(63 days)
The IMAGE1, a camera control unit (CCU), when used with compatible camera heads or videoendoscopes and ancillary equipment, is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescent imaging and documentation of endoscopic and microscopic procedures in adults and pediatrics.
The X-to-4U Adapter, as ancillary equipment, is intended to connect compatible camera heads or videoendoscopes to the IMAGE1 CCU.
The IMAGE1 CCU is the next generation KARL STORZ CCU designed for use by medical professionals in an OR setting to provide real-time visible (VIS) and near-infrared (NIR) fluorescent imaging and documentation of endoscopic and microscopic procedures. The IMAGE1 CCU performs image processing functions including color processing, color filtration, and image enhancement and is compatible with many KARL STORZ C-Line and 4U connector type camera heads. Software extensions and applications can be purchased by the user and downloaded onto the CCU to provide additional features beyond those of the default set.
For compatibility with the X-link connector type camera head and videoendoscopes, IMAGE1 requires the X-to-4U adapter. The X-to-4U Adapter provides an electromechanical interface between the X-Line family of Flexible Videoendoscopes and the 4U-Receptacle of the IMAGE1 CCU.
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