Device typeGastrointestinal endoscopy support software: A software program intended to display, analyse/process, and possibly acquire images of the gastrointestinal tract acquired by an endoscopic device (endoscope or capsule) to assist with the visual examination and treatment of a condition (e.g., polyp detection). It may be capable of differentiating lesions and/or producing a probability score (e.g., neoplastic versus non-neoplastic), and/or adjusting capsule settings [e.g., position in the gastrointestinal (GI) tract]. It does not incorporate adaptive/dynamic machine learning (ML) models.
FDA categoryGastrointestinal Capsule Endoscopy Analysis Software Device
Device ID00860016605909
Catalog numberCLD
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information