# K252617: MiroCam® Capsule Endoscope System

- Pathway: 510(k) (Special)
- Applicant: Intromedic Co., Ltd.
- Decided: May 8, 2026 after 262 days
- Product code: NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule)
- Device class: 2
- Regulation: 21 CFR 876.1300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to DEN010002 (2001). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143663: MiroCam Capsule Endoscope System, Intromedic Co., Ltd. (2015) Summary page 5.
- K180732: MiroCam Capsule Endoscope System, Intromedic Co., Ltd. (2018) Summary page 5.

## Indications for use
The MiroCam® Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from two years of age. The Suspected GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas.

Source page: https://510kreport.com/device/K252617
Methodology: https://510kreport.com/methodology