# K170438: MiroCam Capsule Endoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Intromedic Co., Ltd.
- Decided: Jan 30, 2018 after 351 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: 18 generations back to DEN010002 (2001). 26 ancestors in all.
2 later devices descend from it; 1 cites it directly.
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 4.
- K123864: Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3 Capsule Endoscopy System, Given Imaging, Ltd. (2013) Summary page 4.

## Most influential descendants
- K180732: MiroCam Capsule Endoscope System (2018), 1 descendant of its own
- K252617: MiroCam® Capsule Endoscope System (2026), 0 descendants of its own

## Indications for use
The MiroCam® Capsule Endoscope System is intended for visualization of the small bowel mucosa. - It may be used in the visualization and monitoring of lesions that may indicate Crohn’s disease not detected by upper and lower endoscopy. - It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy. - It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy. It may be used as a tool in the detection of abnormalities of the small bowel and this device is indicated for adults only. 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/K170438
Methodology: https://510kreport.com/methodology