# K111450: Mirocam Capsule Endoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Intromedic Co., Ltd.
- Decided: May 18, 2012 after 359 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: 13 generations back to DEN010002 (2001). 13 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070475: Modificaton to: Given Diagnostic Imaging System, Given Imaging, Ltd. (2007) Summary page 1.

## Most influential descendants
- K123428: Mirocam Capsule Endoscope System (2013), 6 descendants of its own
- K140751: Mirocam Capsule Endoscope System (2014), 5 descendants of its own
- K134005: Mirocam Capsule Endoscope System (2014), 4 descendants of its own
- K143663: MiroCam Capsule Endoscope System (2015), 3 descendants of its own
- K170438: MiroCam Capsule Endoscope System (2018), 2 descendants of its own

## Indications for use
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. 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/K111450
Methodology: https://510kreport.com/methodology