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Updated: Apr 29, 2026

Murine Endoscopy for In Vivo Multimodal Imaging of Carcinogenesis and Assessment of Intestinal Wound Healing and Inflammation
Published on: August 26, 2014
Medical devices; gastroenterology-urology devices; classification of the colon capsule imaging system. Final order
Abstract:
The Food and Drug Administration (FDA) is classifying the colon capsule imaging system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the colon capsule imaging system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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