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The PillCam COLON 2 capsule endoscopy system is intended to provide visualization of the colon. It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible, In addition, it is intended for detection of colon polyps in patients with evidence of gastrointestinal bleeding of lower Gl origin. This applies only to patients with major risks for colonoscopy or moderate sedation, but who could tolerate colonoscopy and moderate sedation in the event a clinically significant colon abnormality was identified on capsule endoscopy.

The Given PillCam Endoscopy system is comprised of four main subsystems; (1) the ingestible PillCam capsule, (2) the DR 3 PillCam Recorder, (3) the RAPID software, and (4) the Given Workstation and Accessories. 1. Ingestible PillCam Capsule The disposable, ingestible PillCam Capsule is designed to acquire video images during the natural propulsion through the GI tract. The capsule transmits the acquired images via a RF communication channel to the PillCam Recorder located outside the body. 2. DR 3 PillCam Recorder Recorder is an external The DR 3 PillCam receiving/recording unit that receives and stores the acquired images from the capsule. The Sensor Array/belt receives data from the PillCam capsule and transfers the data to the PillCam Recorder. 3. RAPID Software The RAPID Software is a software application that is utilized to process, analyze, store, and view the acquired images collected from the PillCam Recorder to create a RAPID video of the images. The software also includes a reporting function to create detailed clinical reports, inservice training videos, and patient instruction forms. 4. Given Workstation and Accessories The Workstation is a modified standard personal computer that is the operational platform for the RAPID software. Other accessories include a flat panel LCD monitor, a highcapacity mass storage device, and a high-capacity USB portable storage device.

The PillCam COLON 2 Capsule Endoscopy System is indicated to provide visualization of the colon. It is intended to be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible.

The PillCam® COLON 2 capsule endoscopy system includes a single-use ingestible capsule designed to acquire video images during natural propulsion through the digestive system. It is specifically designed to visualize the complex anatomy of the colon. The PillCam COLON 2 capsule is designed to withstand the mechanical forces and chemical environment of the digestive system. The system is comprised of four main subsystems; (1) the ingestible PillCam COLON 2 capsule, (2) the DR 3 PillCam® Recorder, (3) the RAPID® software, and (4) the Given® Workstation.