# K182907: SPY Elite Intraoperative Perfusion Assessment System

- Pathway: 510(k) (Traditional)
- Applicant: Novadaq Technologies Ulc. (Now A Part of Stryker)
- Decided: Jan 23, 2019 after 98 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: 7 generations back to K944261 (1994). 22 ancestors in all.
14 later devices descend from it; 4 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100371: Spy Intra-Operative Imaging System, Novadaq Technologies, Inc. (2011) Summary page 4.
- K073088: Spy Fluorescent Imaging System, Novadaq Technologies, Inc. (2008) Summary page 4.
- K073130: Spy Fluorescent Imaging System, Novadaq Technologies, Inc. (2008) Summary page 4.
- K071619: Spy Fluorescent Imaging System, Novadaq Technologies, Inc. (2007) Summary page 4.

## Most influential descendants
- K192174: SPY Portable Handheld Imaging (SPY-PHI) System (2019), 9 descendants of its own
- 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
- K214097: Explorer Air II (2022), 2 descendants of its own

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

Source page: https://510kreport.com/device/K182907
Methodology: https://510kreport.com/methodology