# K261037: 780 nm SPY Portable Handheld Imaging (SPY-PHI) System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: May 28, 2026 after 59 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: 25 generations back to K930667 (1994). 178 ancestors in all.
No later device cites it as a predicate yet.
3 of 179 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230727: SPY Portable Handheld Imaging (SPY-PHI) System, Novadaq Technologies Ulc (A Part of Stryker) (2023) Summary page 5.
- K231854: 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM, Stryker (2023) Summary page 5.

## Indications for use
Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the 780 nm SPY-PHI System is used with SPY AGENT GREEN to perform intraoperative fluorescence angiography. The 780 nm SPY-PHI System is indicated for use in adult and pediatric patients one month of age and older. The 780 nm 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 780 nm 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 780 nm 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. Upon administration and use of pafolacianine consistent with its approved label, the 780 nm SPY-PHI System is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

Source page: https://510kreport.com/device/K261037
Methodology: https://510kreport.com/methodology