# K042961: Spy Intra-Operative Imaging System: SP2000

- Pathway: 510(k) (Traditional)
- Applicant: Novadaq Technologies, Inc.
- Decided: Jan 19, 2005 after 84 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: 1 generation back to K944261 (1994). 2 ancestors in all.
136 later devices descend from it; 11 cite it directly.
0 of 139 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984545: Release 2 of Philips Integris Series (V5000, BV5000, H5000, BH5000, HM2000) Systems, Philips Medical Systems North America, Inc. (1999) Summary page 1.
- K944261: Retina Angiograph, Heidelberg Engineering (1994) Summary page 1.

## Most influential descendants
- K060867: Spy Intraoperative Imaging System (2006), 134 descendants of its own
- K061871: Leica Model FL800 (2006), 133 descendants of its own
- 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

## 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 intra-operative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (CABG) surgery.

Source page: https://510kreport.com/device/K042961
Methodology: https://510kreport.com/methodology