# K063259: Olympus Capsule Endoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Sep 14, 2007 after 319 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: 11 generations back to DEN010002 (2001). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN010002: Given Diagnostic Imaging System, Given Imaging, Ltd. (2001). Our reading of the summary gave K010312, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN010002, Given Diagnostic Imaging System (Given Imaging, Ltd.), granted Aug 1, 2001; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K020341: Given Diagnostic System, Given Imaging, Ltd. (2002)
- K022362: Given Diagnostics System, Given Imaging, Ltd. (2002) Summary page 2.
- K022980: Modification to Given Diagnostic System, Given Imaging, Ltd. (2003) Summary page 2.
- K031033: Given Diagnostic System, Given Imaging, Ltd. (2003) Summary page 2.
- K060805: Modification to Given Diagnostic System, Given Imaging, Ltd. (2006) Summary page 2.

## Indications for use
The OLYMPUS CAPSULE ENDOSCOPE SYSTEM has been designed to be used for visualization of the small intestine mucosa, The Red Color Detection Function is intended to mark frames of the video suspected of containing blood or red areas.

Source page: https://510kreport.com/device/K063259
Methodology: https://510kreport.com/methodology