# K091405: Pillcam Platform with Pillcam SB Capsules with Pillcam Sensorbelt

- Pathway: 510(k) (Special)
- Applicant: Given Imaging, Ltd.
- Decided: Jul 29, 2009 after 78 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.
17 later devices descend from it; 2 cite it directly.
0 of 31 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.
- K062786: Modification to Given Diagnostic System, Given Imaging, Ltd. (2006) Summary page 1.

## Most influential descendants
- K103025: Given Pillcam Platform with Rapid 6.5 / Given Pillcam Platform with Pillcam Eso 3 Capsules (2011), 12 descendants of its own
- K123864: Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3 Capsule Endoscopy System (2013), 11 descendants of its own
- K103088: Given Pillcam Platform with Pillcam SB Capsuleswith Pillcam R Sensorbelt (2011), 6 descendants of its own
- K140751: Mirocam Capsule Endoscope System (2014), 5 descendants of its own
- K170210: PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 (2017), 4 descendants of its own

## Indications for use
The Given PillCam® Platform with the PillCam® 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 10 years of age and up. 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/K091405
Methodology: https://510kreport.com/methodology