# K230407: FloNavi Open Field Fluorescence Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Optomedic Technologies, Inc.
- Decided: Jul 17, 2023 after 152 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: 19 generations back to K930667 (1994). 107 ancestors in all.
No later device cites it as a predicate yet.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200737: SPY Portable Handheld Imaging (SPY-PHI) System, Novadaq Technologies Ulc. (Now A Part of Stryker) (2020) Summary page 5.

## Indications for use
Upon intravenous administration and use of an ICG consistent with its approved labeling, the FloNavi Open Field Fluorescence Imaging System is used to perform intraoperative fluorescence angiography. The FloNavi Open Field Fluorescence Imaging System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after: vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgical procedures. Upon interstitial administration and use of an ICG consistent with its approved labeling, the FloNavi Open Field Fluorescence Imaging 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/K230407
Methodology: https://510kreport.com/methodology