# K100371: Spy Intra-Operative Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Novadaq Technologies, Inc.
- Decided: Feb 4, 2011 after 357 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: 6 generations back to K944261 (1994). 21 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 38 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.
- K063345: Spy Imaging System, Novadaq Technologies, Inc. (2007) Summary page 1.
- K071037: Spy Intra-Operative Imaging System, Model SP2000, Novadaq Technologies, Inc. (2007) Summary page 1.
- K072222: Spy Fluorescent Imaging System, Novadaq Technologies, Inc. (2007) Summary page 1.
- K071619: Spy Fluorescent Imaging System, Novadaq Technologies, Inc. (2007) Summary page 1.
- K073088: Spy Fluorescent Imaging System, Novadaq Technologies, Inc. (2008) Summary page 1.
- K073130: Spy Fluorescent Imaging System, Novadaq Technologies, Inc. (2008) Summary page 1.
- K040675: Axiom Artis U, Siemens Medical Systems, Inc. (2004) Summary page 1.

## Most influential descendants
- K182907: SPY Elite Intraoperative Perfusion Assessment System (2019), 14 descendants of its own
- K162885: SPY Phi Open Field Handheld Fluorescence Imaging System (2017), 10 descendants of its own
- K192174: SPY Portable Handheld Imaging (SPY-PHI) System (2019), 9 descendants of its own
- K200737: SPY Portable Handheld Imaging (SPY-PHI) System (2020), 8 descendants of its own
- K202244: SPY-PHI System with SPY-PHI Fluorescence Assessment Software (2020), 5 descendants of its own

## Indications for use
The SPY System is intended to provide fluorescence images for the visual assessment of blood flow in vessels and related tissue perfusion during gastrointestinal surgical procedures.

Source page: https://510kreport.com/device/K100371
Methodology: https://510kreport.com/methodology