# K103088: Given Pillcam Platform with Pillcam SB Capsuleswith Pillcam R Sensorbelt

- Pathway: 510(k) (Traditional)
- Applicant: Given Imaging, Ltd.
- Decided: Jan 14, 2011 after 87 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: 14 generations back to DEN010002 (2001). 16 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091405: Pillcam Platform with Pillcam SB Capsules with Pillcam Sensorbelt, Given Imaging, Ltd. (2009) Summary page 1.
- K090557: Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given Agile Patency System, Given Imaging, Ltd. (2009) 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

## Indications for use
The Given PillCain® Platform with the PilICain® SB Capsules 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 Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.

Source page: https://510kreport.com/device/K103088
Methodology: https://510kreport.com/methodology