# K182606: PINPOINT Endoscopic Fluorescence Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Novadaq Technologies Ulc. (Now A Part of Stryker)
- Decided: Nov 21, 2018 after 61 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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: 17 generations back to K930667 (1994). 85 ancestors in all.
44 later devices descend from it; 12 cite it directly.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150956: PINPOINT Endoscopic Fluorescence Imaging System, Novadaq Technologies, Inc. (2016) Summary page 4.
- K161792: PINPOINT Endoscopic Fluorescence Imaging System, Novadaq Technologies, Inc. (2016) Summary page 4.

## Most influential descendants
- K200737: SPY Portable Handheld Imaging (SPY-PHI) System (2020), 8 descendants of its own
- K202925: KARL STORZ ICG Imaging System (2020), 7 descendants of its own
- K191851: VS3-IR (2019), 6 descendants of its own
- K231854: 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM (2023), 5 descendants of its own
- K210265: VS3 Iridium Sytem (2021), 5 descendants of its own

## Indications for use
Upon intravenous administration of TRADENAME (ICG drug product), the PINPOINT Endoscopic Fluorescence Imaging System is used with TRADENAME to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when indicated, during intraoperative cholangiography. The PINPOINT Endoscopic Fluorescence Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. The PINPOINT System enables 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 or common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the PINPOINT System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization. Upon interstitial administration of TRADENAME (ICG drug product), the PINPOINT System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Source page: https://510kreport.com/device/K182606
Methodology: https://510kreport.com/methodology