# K203550: ActivSight Intraoperative Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Activ Surgical, Inc.
- Decided: Apr 8, 2021 after 125 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: 14 generations back to K930667 (1994). 72 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K254180: PerfusiX-Imaging (2026), 0 descendants of its own
- K231344: ActivSight Intraoperative Imaging System (2023), 0 descendants of its own

## Indications for use
ActivSight is intended to provide real-time endoscopic fluorescence and near infrared imaging. ActivSight enables surgeons to visually assess vessels, blood flow, and related tissue perfusion using fluorescence and near infrared imaging, and at least one of the major bile ducts (cystic duct, common bile duct or common hepatic duct) using fluorescence, all during minimally invasive surgery. Fluorescence imaging of biliary ducts with ActivSight is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for stand-alone use for biliary duct visualization.

Source page: https://510kreport.com/device/K203550
Methodology: https://510kreport.com/methodology