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The CapsoCam Plus SV-3 capsule endoscopy system is intended for visualization of the small bowel mucosa in adults and children older than two years of age. It may be used as a tool in the detection of abnormalities of the small bowel.

The primary component of the CapsoCam Plus (SV-3) capsule endoscopy system is the eponymous single-use, ingestible capsule that acquires and stores video images in on-board memory while moving through the gastrointestinal tract, propelled by natural peristalsis. It is administered under medical supervision either in-person or remotely under video guidance (available for adult patients only). The capsule is typically excreted within 3 to 30 hours after swallowing. Upon excretion, the patient/authorized caregiver retrieves the capsule using the provided retrieval kit and returns it to the capsules to the download center in a pre-paid envelope) where the capsule is processed and data is downloaded. The system consists of the following hardware components and accessories: - CapsoCam Plus (SV-3) capsules, which are intended for visualization of the small bowel mucosa. - CapsoRetrieve (CVR1) Capsule Retrieval Kit, a kit of non-powered tools used for the collection, storage, and transportation of the excreted CapsoCam Plus (SV-3) capsules. - CapsoAccess (CDAS) Capsule Data Access System, a dock which facilitates download/access of data from the SV-3 capsules. The system also includes software that is unchanged from K192662.