# K060867: Spy Intraoperative Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Novadaq Technologies, Inc.
- Decided: May 3, 2006 after 34 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: 2 generations back to K944261 (1994). 3 ancestors in all.
134 later devices descend from it; 8 cite it directly.
0 of 138 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.

## Most influential descendants
- K071037: Spy Intra-Operative Imaging System, Model SP2000 (2007), 131 descendants of its own
- K063345: Spy Imaging System (2007), 131 descendants of its own
- 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

## 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
For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (CABG) surgery.

Source page: https://510kreport.com/device/K060867
Methodology: https://510kreport.com/methodology