# K151243: STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Aug 20, 2015 after 101 days
- Product code: FCS (Light, Catheter, Fiberoptic, Glass, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.4020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K930667 (1994). 75 ancestors in all.
34 later devices descend from it; 2 cite it directly.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061548: Stryker Ureteral Illumination System IV, Stryker Corp. (2006) Summary page 4.
- K142310: Stryker Infrared Fluorescence (IRF) Imaging System, Stryker Endoscopy (2014) Summary page 4.

## Most influential descendants
- K182160: 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM (2018), 33 descendants of its own
- K202592: Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality) (2020), 26 descendants of its own
- K210088: 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes (2021), 25 descendants of its own
- K211202: 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes (2021), 19 descendants of its own
- K214046: 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable (2022), 14 descendants of its own

## Indications for use
The Stryker AIM Light Source is intended to trans-illuminate anatomical structures during open or laparoscopic surgical procedures. The Stryker® AIM Light Source and SafeLight Cable are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The Stryker® AIM 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® AIM 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. The Stryker IRIS Ureteral Kit when used with compatible Stryker Infrared sources is intended to trans-illuminate the ureter during surgical procedures. The catheter accepts up to 0.038” guide wire. The kit can be used for either open surgical or laparoscopic procedures.

Source page: https://510kreport.com/device/K151243
Methodology: https://510kreport.com/methodology