# K240276: PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software

- Pathway: 510(k) (Traditional)
- Applicant: Given Imaging Ltd. (D.B.A. Medtronic)
- Decided: May 10, 2024 after 100 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: 19 generations back to DEN010002 (2001). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230991: PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E, Given Imaging Ltd. (Medtronic) (2023) Summary page 6.

## Indications for use
The PillCam™ Genius SB Capsule Endoscopy Kit with the PillCam Genius 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 PillCam Genius SB Capsule may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults.

Source page: https://510kreport.com/device/K240276
Methodology: https://510kreport.com/methodology