510(k) · Cleared

Cleared

Spy Fluorescent Imaging System

K073130510(k) TraditionalCleared Jan 10, 200865-day reviewClass II21 CFR 892.1600

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Novadaq Technologies, Inc. · IZI System, X-Ray, Angiographic

Cleared on Jan 10, 2008 as substantially equivalent to K042961 (Novadaq Technologies, Inc., 2005) and 6 other predicates after a 65-day review. Its family tree reaches back 5 generations to 1994. 20 later devices descend from it.

Decided: Jan 10, 2008
Review: 65 days
Class: Class II
Product code: IZI
Recalls: None
Predicates: 7

Its longest line of descent runs back 5 generations to K944261 (1994). 9 ancestors in all. 20 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 5 generations backK944261 Retina AngiographHeidelberg Engineering · 1994
4 generations backK042961 Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc. · 2005 · Recalled
3 generations backK060867 Spy Intraoperative Imaging SystemNovadaq Technologies, Inc. · 2006 · Recalled
2 generations backK063345 Spy Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
1 generation backK072222 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
This deviceK073130 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2008
Descendant · cites it directly · 16 of its ownK100371 Spy Intra-Operative Imaging SystemNovadaq Technologies, Inc. · 2011
Descendant · cites it directly · 14 of its ownK182907 SPY Elite Intraoperative Perfusion Assessment SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2019
Descendant · cites it directly · 13 of its ownK110480 Pde Photodynamic EyeHamamatsu Photonics K.K. · 2012
Descendant · 2 generations on · 11 of its ownK133719 Pde-NeoHamamatsu Photonics K.K. · 2014
Descendant · 2 generations on · 10 of its ownK162885 SPY Phi Open Field Handheld Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2017 · Recalled

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2011high 3 (2020) · low 0 (2013)2026

Most influential descendants

Showing 5 of 20 · See all

K100371Spy Intra-Operative Imaging SystemNovadaq Technologies, Inc. · 2011 · cites it directly16descendants
K182907SPY Elite Intraoperative Perfusion Assessment SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2019 · cites it directly14descendants
K110480Pde Photodynamic EyeHamamatsu Photonics K.K. · 2012 · cites it directly13descendants
K133719Pde-NeoHamamatsu Photonics K.K. · 2014 · 2 generations on11descendants
K162885SPY Phi Open Field Handheld Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2017 · 2 generations on10descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K944261	Retina Angiograph	Heidelberg Engineering	1994	—
−4	K042961	Spy Intra-Operative Imaging System: SP2000	Novadaq Technologies, Inc.	2005	1
−3	K060867	Spy Intraoperative Imaging System	Novadaq Technologies, Inc.	2006	1
−2	K063345	Spy Imaging System	Novadaq Technologies, Inc.	2007	1
−1	K072222	Spy Fluorescent Imaging System	Novadaq Technologies, Inc.	2007	1
0 (this device)	K073130	Spy Fluorescent Imaging System	Novadaq Technologies, Inc.	2008	—
+1	K100371	Spy Intra-Operative Imaging System	Novadaq Technologies, Inc.	2011	—
+1	K182907	SPY Elite Intraoperative Perfusion Assessment System	Novadaq Technologies Ulc. (Now A Part of Stryker)	2019	—
+1	K110480	Pde Photodynamic Eye	Hamamatsu Photonics K.K.	2012	—
+2	K133719	Pde-Neo	Hamamatsu Photonics K.K.	2014	—
+2	K162885	SPY Phi Open Field Handheld Fluorescence Imaging System	Novadaq Technologies, Inc.	2017	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2006	1	0
2007	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	1	0
2014	1	0
2015	1	0
2017	1	0
2019	2	0
2020	3	0
2022	1	0
2023	3	0
2024	1	0
2025	2	0
2026	3	0

FIG. 1 — Lineage of K073130, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IZI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new IZI device

#1 K230727 SPY Portable Handheld Imaging (SPY-PHI) Systemscore 23.2 · 20 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (7)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K042961	Spy Intra-Operative Imaging System: SP2000 Summary page 2 …Y System with the SP2000 Imaging Device) had received initial FDA 510(k) clearance far market for use during coronary artery bypass graft (CABG) surgery in January 2005 (K042961). Subsequent 510(k) clearance was obtained in May 2006 (K060867) for a labeling change, followed by a clearance for use in plasti…	Novadaq Technologies, Inc.	2005	1
*	K060867	Spy Intraoperative Imaging System Summary page 2 …A 510(k) clearance far market for use during coronary artery bypass graft (CABG) surgery in January 2005 (K042961). Subsequent 510(k) clearance was obtained in May 2006 (K060867) for a labeling change, followed by a clearance for use in plastic, micro- and reconstructive surgery in January 2007 (K063345),…	Novadaq Technologies, Inc.	2006	1
*	K063345	Spy Imaging System Summary page 2 …510(k) clearance was obtained in May 2006 (K060867) for a labeling change, followed by a clearance for use in plastic, micro- and reconstructive surgery in January 2007 (K063345), and a clearance for use of an alternative brand of fluorescent ICG agent in coronary artery bypass surgery in May 2007 (K071037…	Novadaq Technologies, Inc.	2007	1
*	K071037	Spy Intra-Operative Imaging System, Model SP2000 Summary page 2 …reconstructive surgery in January 2007 (K063345), and a clearance for use of an alternative brand of fluorescent ICG agent in coronary artery bypass surgery in May 2007 (K071037), as well as in the plastic, micro-, and reconstructive surgery in September 2007 (K072222). In addition, the SPY Fluorescent Ima…	Novadaq Technologies, Inc.	2007	1
*	K072222	Spy Fluorescent Imaging System Summary page 2 …brand of fluorescent ICG agent in coronary artery bypass surgery in May 2007 (K071037), as well as in the plastic, micro-, and reconstructive surgery in September 2007 (K072222). In addition, the SPY Fluorescent Imaging System (SPY System with the SP2000 Imaging Device) recently received FDA 510(k) cleara…	Novadaq Technologies, Inc.	2007	1
*	K071619	Spy Fluorescent Imaging System Cleared while this submission was under review Summary page 2 …, the SPY Fluorescent Imaging System (SPY System with the SP2000 Imaging Device) recently received FDA 510(k) clearance for market for its use in cardiovascular surgery (K071619). The Leica FL800 had received FDA 510(k) clearance for market in September 2006 (K061871). The Leica FL800 is intended for use…	Novadaq Technologies, Inc.	2007	3
*	K061871	Leica Model FL800 Summary page 2 …eceived FDA 510(k) clearance for market for its use in cardiovascular surgery (K071619). The Leica FL800 had received FDA 510(k) clearance for market in September 2006 (K061871). The Leica FL800 is intended for use to allow neurosurgeons to view blood flow.…	Leica Microsystems, Inc.	2006	—

Also cleared against K042961: 10 other devices →

What descends from it? (20)

See all 20

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K100371	Spy Intra-Operative Imaging System	Novadaq Technologies, Inc.	2011	16
K182907	SPY Elite Intraoperative Perfusion Assessment System	Novadaq Technologies Ulc. (Now A Part of Stryker)	2019	14
K110480	Pde Photodynamic Eye	Hamamatsu Photonics K.K.	2012	13

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 8 months on median.
7 of the 9 ancestors have a recall of any class.
Of its descendants, K100371 (Novadaq Technologies, Inc., 2011) has gone furthest, with 16 descendants of its own.
10 other devices also cite its predicate K042961.

How does its category compare?

All IZI devices

IZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · IZI

2in 2025

2007high 7 (2007) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IZI

81in 2023

2007high 111 (2014) · low 28 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IZI

1in 2021

2007high 52 (2008) · low 0 (2022)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IZI

2,171in 2025

2007high 2,171 (2025) · low 14 (2020)2025

MAUDE reports naming product code IZI, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	7	28	6	92
2008	6	68	52	101
2009	2	—	18	132
2010	2	—	11	252
2011	4	104	6	377
2012	1	—	6	77
2013	1	—	6	58
2014	4	111	5	123
2015	0	—	14	36
2016	1	—	7	102
2017	2	—	1	88
2018	2	—	2	49
2019	2	—	2	30
2020	1	—	2	14
2021	1	—	1	29
2022	1	—	0	265
2023	3	81	0	1,204
2024	2	—	0	1,332
2025	2	—	0	2,171
2026	2	—	1	—

What is it indicated for?

The SPY® Fluorescent Imaging System is intended to intra-operatively enable surgeons to visually assess blood flow and related tissue perfusion during organ transplant procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K073130 · printed Nov 5, 2026

Cite this page

510(k) Report. “K073130: Spy Fluorescent Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073130

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026