# K192174: SPY Portable Handheld Imaging (SPY-PHI) System

- Pathway: 510(k) (Traditional)
- Applicant: Novadaq Technologies Ulc. (Now A Part of Stryker)
- Decided: Nov 15, 2019 after 95 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: 9 generations back to K944261 (1994). 28 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190729: SPY Portable Handheld Imaging (SPY-PHI) System, Novadaq Technologies Ulc. (Now A Part of Stryker) (2019) Summary page 4.
- K162885: SPY Phi Open Field Handheld Fluorescence Imaging System, Novadaq Technologies, Inc. (2017) Summary page 4.
- K182907: SPY Elite Intraoperative Perfusion Assessment System, Novadaq Technologies Ulc. (Now A Part of Stryker) (2019) Summary page 4.

## Most influential descendants
- K200737: SPY Portable Handheld Imaging (SPY-PHI) System (2020), 8 descendants of its own
- K202244: SPY-PHI System with SPY-PHI Fluorescence Assessment Software (2020), 5 descendants of its own
- K230727: SPY Portable Handheld Imaging (SPY-PHI) System (2023), 4 descendants of its own
- K261037: 780 nm SPY Portable Handheld Imaging (SPY-PHI) System (2026), 0 descendants of its own
- K253181: SURGIMAGE SIM 1000H Fluorescence Imaging Platform (2026), 0 descendants of its own

## Indications for use
Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP) the SPY-PHI System is used with SPY AGENT™ GREEN to perform intraoperative fluorescence angiography. The SPY-PHI System is indicated for use in adult and pediatric patients one month of age and older. The SPY-PHI 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.

Source page: https://510kreport.com/device/K192174
Methodology: https://510kreport.com/methodology