# K123864: Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3 Capsule Endoscopy System

- Pathway: 510(k) (Traditional)
- Applicant: Given Imaging, Ltd.
- Decided: Aug 12, 2013 after 238 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: 15 generations back to DEN010002 (2001). 19 ancestors in all.
11 later devices descend from it; 6 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)
- K103025: Given Pillcam Platform with Rapid 6.5 / Given Pillcam Platform with Pillcam Eso 3 Capsules, Given Imaging, Ltd. (2011) Summary page 1.
- K101250: Given Pillcam Platform with Pillcam SB Capsules, Given Imaging, Ltd. (2011) Summary page 1.

## Most influential descendants
- K170210: PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 (2017), 4 descendants of its own
- K211684: PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E (2021), 3 descendants of its own
- K170438: MiroCam Capsule Endoscope System (2018), 2 descendants of its own
- K230991: PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E (2023), 1 descendant of its own
- K180732: MiroCam Capsule Endoscope System (2018), 1 descendant of its own

## Indications for use
With PillCam SB Capsule The PillCam SB capsule 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. The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas. The PillCam SB capsule may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age. With PillCam ESO Capsule The PillCam capsule endoscopy system with PillCam ESO capsules is intended for the visualization of esophageal mucosa.

Source page: https://510kreport.com/device/K123864
Methodology: https://510kreport.com/methodology