# K060805: Modification to Given Diagnostic System

- Pathway: 510(k) (Special)
- Applicant: Given Imaging, Ltd.
- Decided: May 24, 2006 after 61 days
- Product code: NSI (System, Imaging, Esophageal, 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: 10 generations back to DEN010002 (2001). 10 ancestors in all.
28 later devices descend from it; 4 cite it directly.
0 of 39 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) Summary page 1.
- K022362: Given Diagnostics System, Given Imaging, Ltd. (2002) Summary page 1.
- K022980: Modification to Given Diagnostic System, Given Imaging, Ltd. (2003) Summary page 1.
- K031033: Given Diagnostic System, Given Imaging, Ltd. (2003) Summary page 1.
- K032405: Given Diagnostic System, Given Imaging, Ltd. (2003) Summary page 1.
- K040248: Modification to Given Diagnostic System, Given Imaging, Ltd. (2004) Summary page 1.
- K052184: Given Diagnostic System, Given Imaging, Ltd. (2005) Summary page 1.
- K041149: Given Diagnostic System with M2A Eso Capsule, Given Imaging, Ltd. (2004) Summary page 1.
- K042960: Given Diagnostic System with Pillcam Eso, Given Imaging, Ltd. (2004) Summary page 1.

## Most influential descendants
- K062786: Modification to Given Diagnostic System (2006), 26 descendants of its own
- K070475: Modificaton to: Given Diagnostic Imaging System (2007), 25 descendants of its own
- K090557: Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given Agile Patency System (2009), 19 descendants of its own
- K091405: Pillcam Platform with Pillcam SB Capsules with Pillcam Sensorbelt (2009), 17 descendants of its own
- K103025: Given Pillcam Platform with Rapid 6.5 / Given Pillcam Platform with Pillcam Eso 3 Capsules (2011), 12 descendants of its own

## Indications for use
The Given® Diagnostic System with the PillCam™ SB Capsule is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from 10 years of age and up The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas The Given® Diagnostic System with the PillCam™ ESO Capsule is intended for the visualization of esophageal mucosa.

Source page: https://510kreport.com/device/K060805
Methodology: https://510kreport.com/methodology