# K063345: Spy Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Novadaq Technologies, Inc.
- Decided: Jan 12, 2007 after 67 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K944261 (1994). 5 ancestors in all.
131 later devices descend from it; 8 cite it directly.
0 of 137 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.
- K061871: Leica Model FL800, Leica Microsystems, Inc. (2006) Summary page 1.

## Most influential descendants
- K072222: Spy Fluorescent Imaging System (2007), 129 descendants of its own
- K073088: Spy Fluorescent Imaging System (2008), 119 descendants of its own
- K091515: Spy Scope Intra-Operative Operating System (2009), 106 descendants of its own
- K101077: DA Vinci Fluorescence Imaging Vision System, Model FF 100 (2011), 104 descendants of its own
- K124031: DA Vinci Fluorescence Imaging Vision System (2013), 103 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.

## Indications for use
The SPY System is an imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion,. and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.

Source page: https://510kreport.com/device/K063345
Methodology: https://510kreport.com/methodology