# K071619: Spy Fluorescent Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Novadaq Technologies, Inc.
- Decided: Nov 9, 2007 after 149 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K944261 (1994). 6 ancestors in all.
26 later devices descend from it; 4 cite it directly.
0 of 33 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 1.
- K060867: Spy Intraoperative Imaging System, Novadaq Technologies, Inc. (2006) Summary page 1.
- K071037: Spy Intra-Operative Imaging System, Model SP2000, Novadaq Technologies, Inc. (2007) Summary page 1.
- K061871: Leica Model FL800, Leica Microsystems, Inc. (2006) Summary page 1.

## Most influential descendants
- K073130: Spy Fluorescent Imaging System (2008), 20 descendants of its own
- 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

## Recalls of this device
- Aug 18, 2016 · Class II · Z-2767-2016: Novadaq is informing SK6000 PAQ users that a pinhole through the drape pouch film material was identified in some SK6000 PAQs during shipping validation testing.
- Nov 4, 2014 · Class III · Z-0470-2015: Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.
- Nov 4, 2014 · Class III · Z-0469-2015: Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.

## Indications for use
The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures,

Source page: https://510kreport.com/device/K071619
Methodology: https://510kreport.com/methodology