# K242163: SmartSurgN Visualization System

- Pathway: 510(k) (Traditional)
- Applicant: SmartsurgN, Inc.
- Decided: Apr 20, 2026 after 635 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: 15 generations back to K930667 (1994). 72 ancestors in all.
No later device cites it as a predicate yet.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213943: SmartSurgN Visualization System, Smartsurgn Incorporated (2022) Summary page 6.

## Indications for use
The SmartSurgN Visualization System is intended to provide realtime endoscopic visible (VIS) and real-time near-infrared (NIR) fluorescence imaging. Upon intravenous administration and use of an ICG consistent with its approved label the SmartSurgN Visualization System enables surgeons to perform minimally invasive surgery using standard endoscopic 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 SmartSurgN Visualization 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/K242163
Methodology: https://510kreport.com/methodology