# K150956: PINPOINT Endoscopic Fluorescence Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Novadaq Technologies, Inc.
- Decided: May 23, 2016 after 410 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K930667 (1994). 83 ancestors in all.
70 later devices descend from it; 5 cite it directly.
0 of 154 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091515: Spy Scope Intra-Operative Operating System, Novadaq Technologies, Inc. (2009) Summary page 4.
- K141077: DA Vinci Firefly Imaging System, Intuitive Surgical, Inc. (2014) Summary page 4.
- K142310: Stryker Infrared Fluorescence (IRF) Imaging System, Stryker Endoscopy (2014) Summary page 4.

## Most influential descendants
- K161792: PINPOINT Endoscopic Fluorescence Imaging System (2016), 68 descendants of its own
- K182606: PINPOINT Endoscopic Fluorescence Imaging System (2018), 44 descendants of its own
- 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

## Recalls of this device
- Feb 26, 2021 · Class II · Z-1428-2021: Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots.

## Indications for use
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.

Source page: https://510kreport.com/device/K150956
Methodology: https://510kreport.com/methodology