# K170210: PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0

- Pathway: 510(k) (Traditional)
- Applicant: Given Imaging, Ltd.
- Decided: Sep 1, 2017 after 220 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: 16 generations back to DEN010002 (2001). 22 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123864: Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3 Capsule Endoscopy System, Given Imaging, Ltd. (2013) Summary page 7.
- K153466: PillCam COLON 2 Capsule Endoscopy System, Given Imaging, Ltd. (2016) Summary page 7.

## Most influential descendants
- K211684: PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E (2021), 3 descendants of its own
- K230991: PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E (2023), 1 descendant of its own
- K242643: CapsoCam Plus (SV-3) Capsule Endoscopy System (2024), 0 descendants of its own
- K240276: PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software (2024), 0 descendants of its own

## Indications for use
The PillCam SBC capsule is intended for visualization of the small bowel and colonic mucosa. It may be used in the visualization and monitoring of lesions in the small bowel that may indicate Crohn’s disease not detected by upper and lower endoscopy, and for the visualization of inflammation of the colon in patients with colonoscopy-diagnosed Crohn’s disease. It may be used in the visualization and monitoring in the small bowel of lesions that may be a source of obscure bleeding (either overt or occult) or that may be potential causes of iron deficiency anemia (IDA) not detected by initial upper and lower endoscopy. The PillCam SBC capsule may be used as a tool in the detection of abnormalities of the small bowel. It is intended for use in adults. With PillCam SB 2/ SB 3 Capsule The PillCam SB 2/ SB 3 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 2/ SB 3 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 UGI Capsule The PillCam UGI capsule endoscopy system is intended for visualization of the upper gastrointestinal tract (esophagus, stomach, duodenum). It may be used for visualization of blood in the upper gastrointestinal tract (esophagus, stomach, duodenum) in patients who are hemodynamically stable and at feast 18 years of age. With PillCam COLON 2 Capsule The PillCam COLON 2 capsule endoscopy system is intended to provide visualization of the colon. It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible. In addition, it is intended for detection of colon polyps in patients with evidence of gastrointestinal bleeding of lower GI origin. This applies only to patients with major risks for colonoscopy or moderate sedation, but who could tolerate colonoscopy and moderate sedation in the event a clinically significant colon abnormality was identified on capsule endoscopy. With PillCam SBC Capsule The PillCam SBC capsule is intended for visualization of the small bowel and colonic mucosa. It may be used in the visualization and monitoring of lesions in the small bowel that may indicate Crohn’s disease not detected by upper and lower endoscopy, and for the visualization of inflammation of the colon in patients with colonoscopy-diagnosed Crohn’s disease. It may be used in the visualization and monitoring in the small bowel of lesions that may be a source of obscure bleeding (either overt or occult) or that may be potential causes of iron deficiency anemia (IDA) not detected by initial upper and lower endoscopy. The PillCam SBC capsule may be used as a tool in the detection of abnormalities of the small bowel. It is intended for use in adults.

Source page: https://510kreport.com/device/K170210
Methodology: https://510kreport.com/methodology