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The Fujinon ultrasonic processor SU-8000 is intended to be used in combination with Fujinon/Fujifilm ultrasonic endoscope, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, recording and to aid in diagnosis during endoscopic evaluation. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application: General Application Specific: Tran-esoph. (non-Card.), Other (Specify) Mode of Operation: B, M, PWD, Color Doppler, Combined1 Other includes gastro-intestinal tract and surrounding organs

Fujinon Ultrasonic Processor SU-8000 is a new ultrasonic processor, which can be used with the previously-cleared ultrasonic gastrointestinal endoscopes, EG-530UR and EG-590UT via K063847. Fujinon Ultrasonic Processor SU-8000 consists of a scan engine and a function box and SU-8000 is controlled by keyboard (model: CP-8000) SU-8000 connects to ultrasonic endoscopes, which emits ultrasound in a body cavity by driving ultrasonic transducers of the endoscope. SU-8000 also processes the reflection of ultrasonic signals the transducer and converts it to an ultrasound image. SU-8000 is used in combination with ultrasonic endoscopes, video processor, light source, cart, recorder, foot switch and other peripheral devices (e.g. external monitor and printer), which is the same as the legally marketed device, SU-7000.