# K142310: Stryker Infrared Fluorescence (IRF) Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Dec 2, 2014 after 105 days
- Product code: OWN (Confocal Optical Imaging)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K930667 (1994). 71 ancestors in all.
76 later devices descend from it; 6 cite it directly.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124031: DA Vinci Fluorescence Imaging Vision System, Intuitive Surgical, Inc. (2013) Summary page 4.
- K132785: Stryker 1488 HD Video Camera with Infrared Compatibility, Stryker Endoscopy (2013) Summary page 4.
- K910132: Stryker Laparoscope, Stryker Corp. (1991) Summary page 4.

## Most influential descendants
- K150956: PINPOINT Endoscopic Fluorescence Imaging System (2016), 70 descendants of its own
- K161792: PINPOINT Endoscopic Fluorescence Imaging System (2016), 68 descendants of its own
- K182606: PINPOINT Endoscopic Fluorescence Imaging System (2018), 44 descendants of its own
- K173866: Stryker AIM Light Source and SafeLight cable (2018), 34 descendants of its own
- K151243: STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit] (2015), 34 descendants of its own

## Indications for use
The Stryker® IRF Light Source and SafeLight Cable are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The Stryker® IRF Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the Stryker® IRF Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the Stryker® IRF Light Source and SafeLight Cable are intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.

Source page: https://510kreport.com/device/K142310
Methodology: https://510kreport.com/methodology