# K123428: Mirocam Capsule Endoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Intromedic Co., Ltd.
- Decided: May 20, 2013 after 194 days
- Product code: NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule)
- Device class: 2
- Regulation: 21 CFR 876.1300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to DEN010002 (2001). 14 ancestors in all.
6 later devices descend from it; 2 cite 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)
- K111450: Mirocam Capsule Endoscope System, Intromedic Co., Ltd. (2012) Summary page 1.

## Most influential descendants
- 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
- K180732: MiroCam Capsule Endoscope System (2018), 1 descendant of its own

## Recalls of this device
- Feb 15, 2017 · Class II · Z-1615-2018: When a user switches on MR1100 Receiver, even though the battery was fully charged, the LED was displayed as orange color due to momentary drop of battery voltage.

## Indications for use
MiroCam® Capsule Endloscope 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/K123428
Methodology: https://510kreport.com/methodology