# DEN010002: Given Diagnostic Imaging System

- Pathway: De Novo (Post-NSE)
- Applicant: Given Imaging, Ltd.
- Decided: Aug 1, 2001 after 51 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
No predicates in its family tree.
40 later devices descend from it; 13 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K020341: Given Diagnostic System (2002), 39 descendants of its own
- K022362: Given Diagnostics System (2002), 38 descendants of its own
- K022980: Modification to Given Diagnostic System (2003), 37 descendants of its own
- K031033: Given Diagnostic System (2003), 36 descendants of its own
- K032405: Given Diagnostic System (2003), 35 descendants of its own

Source page: https://510kreport.com/device/DEN010002
Methodology: https://510kreport.com/methodology