# K073130: Spy Fluorescent Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Novadaq Technologies, Inc.
- Decided: Jan 10, 2008 after 65 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: 5 generations back to K944261 (1994). 9 ancestors in all.
20 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042961: Spy Intra-Operative Imaging System: SP2000, Novadaq Technologies, Inc. (2005) Summary page 2.
- K060867: Spy Intraoperative Imaging System, Novadaq Technologies, Inc. (2006) Summary page 2.
- K063345: Spy Imaging System, Novadaq Technologies, Inc. (2007) Summary page 2.
- K071037: Spy Intra-Operative Imaging System, Model SP2000, Novadaq Technologies, Inc. (2007) Summary page 2.
- K072222: Spy Fluorescent Imaging System, Novadaq Technologies, Inc. (2007) Summary page 2.
- K071619: Spy Fluorescent Imaging System, Novadaq Technologies, Inc. (2007). Cleared while this submission was under review Summary page 2.
- K061871: Leica Model FL800, Leica Microsystems, Inc. (2006) Summary page 2.

## Most influential descendants
- K100371: Spy Intra-Operative Imaging System (2011), 16 descendants of its own
- K182907: SPY Elite Intraoperative Perfusion Assessment System (2019), 14 descendants of its own
- K110480: Pde Photodynamic Eye (2012), 13 descendants of its own
- K133719: Pde-Neo (2014), 11 descendants of its own
- K162885: SPY Phi Open Field Handheld Fluorescence Imaging System (2017), 10 descendants of its own

## Indications for use
The SPY® Fluorescent Imaging System is intended to intra-operatively enable surgeons to visually assess blood flow and related tissue perfusion during organ transplant procedures.

Source page: https://510kreport.com/device/K073130
Methodology: https://510kreport.com/methodology