# K230991: PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E

- Pathway: 510(k) (Special)
- Applicant: Given Imaging Ltd. (Medtronic)
- Decided: Jun 30, 2023 after 85 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). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211684: PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E, Given Imaging Ltd. (Medtronic) (2021) Summary page 4.

## Most influential descendants
- 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 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 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.

Source page: https://510kreport.com/device/K230991
Methodology: https://510kreport.com/methodology