# K230727: SPY Portable Handheld Imaging (SPY-PHI) System

- Pathway: 510(k) (Traditional)
- Applicant: Novadaq Technologies Ulc (A Part of Stryker)
- Decided: Jun 5, 2023 after 81 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K930667 (1994). 108 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202244: SPY-PHI System with SPY-PHI Fluorescence Assessment Software, Novadaq Technologies Ulc. (Now A Part of Stryker) (2020) Summary page 4.
- K200737: SPY Portable Handheld Imaging (SPY-PHI) System, Novadaq Technologies Ulc. (Now A Part of Stryker) (2020) Summary page 4.

## Most influential descendants
- 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
- K254242: KARL STORZ ICG Imaging System with RUBINA® Lens (2026), 0 descendants of its own
- K243645: IC-Flow™ Imaging System 2.0 (2025), 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. Upon interstitial administration of SPY AGENT GREEN, the SPY-PHI System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. Upon intradermal administration of SPY AGENT GREEN, the SPY-PHI System is indicated for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in adults with breast cancer for which this procedure is a component of intraoperative management.

Source page: https://510kreport.com/device/K230727
Methodology: https://510kreport.com/methodology