510(k) · Cleared

Cleared

Spy Fluorescent Imaging System

K073088510(k) TraditionalCleared Jan 10, 200870-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 5 other predicates after a 70-day review. Its family tree reaches back 5 generations to 1994. 119 later devices descend from it.

Decided: Jan 10, 2008
Review: 70 days
Class: Class II
Product code: IZI
Recalls: None
Predicates: 6

Its longest line of descent runs back 5 generations to K944261 (1994). 8 ancestors in all. 119 later devices descend from it, 5 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 deviceK073088 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2008
Descendant · cites it directly · 106 of its ownK091515 Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc. · 2009 · Recalled
Descendant · 2 generations on · 104 of its ownK101077 DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc. · 2011 · Recalled
Descendant · 3 generations on · 103 of its ownK124031 DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc. · 2013
Descendant · 3 generations on · 87 of its ownK141077 DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · Recalled
Descendant · 4 generations on · 76 of its ownK142310 Stryker Infrared Fluorescence (IRF) Imaging SystemStryker Endoscopy · 2014

Showing 5 of 119 descendants. See all descendants

Descendants cleared per year

2009high 18 (2026) · low 0 (2012)2026

Most influential descendants

Showing 5 of 119 · See all

K091515Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc. · 2009 · cites it directly106descendants
K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc. · 2011 · 2 generations on104descendants
K124031DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc. · 2013 · 3 generations on103descendants
K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · 3 generations on87descendants
K142310Stryker Infrared Fluorescence (IRF) Imaging SystemStryker Endoscopy · 2014 · 4 generations on76descendants

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)	K073088	Spy Fluorescent Imaging System	Novadaq Technologies, Inc.	2008	—
+1	K091515	Spy Scope Intra-Operative Operating System	Novadaq Technologies, Inc.	2009	1
+2	K101077	DA Vinci Fluorescence Imaging Vision System, Model FF 100	Intuitive Surgical, Inc.	2011	2
+3	K124031	DA Vinci Fluorescence Imaging Vision System	Intuitive Surgical, Inc.	2013	—
+3	K141077	DA Vinci Firefly Imaging System	Intuitive Surgical, Inc.	2014	2
+4	K142310	Stryker Infrared Fluorescence (IRF) Imaging System	Stryker Endoscopy	2014	—

Other ancestors by year cleared

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	1	0
2011	2	0
2013	1	0
2014	3	0
2015	2	0
2016	3	0
2017	4	0
2018	4	0
2019	5	0
2020	8	0
2021	10	0
2022	12	0
2023	15	0
2024	14	0
2025	16	0
2026	18	0

FIG. 1 — Lineage of K073088, 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

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What was it cleared against? (6)

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 1 …(SPY System) with the SP2000 Imaging Device had received initial FDA 510(k) clearance for market 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 1 …l FDA 510(k) clearance for market 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 1 …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 1 …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), pending drug approval. The Leica FL…	Novadaq Technologies, Inc.	2007	1
*	K072222	Spy Fluorescent Imaging System Summary page 1 …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), pending drug approval. The Leica FL800 had received FDA 510(k) clearance for market in September 2006 (K061871). The Leica FL8…	Novadaq Technologies, Inc.	2007	1
*	K061871	Leica Model FL800 Summary page 1 …, micro-, and reconstructive surgery in September 2007 (K072222), pending drug approval. 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. NOVADAQ Technologies Inc. 510(k)…	Leica Microsystems, Inc.	2006	—

Also cleared against K042961: 10 other devices →

What descends from it? (119)

See all 119

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

Number	Device	Applicant	Decided	Descendants
K091515	Spy Scope Intra-Operative Operating System	Novadaq Technologies, Inc.	2009	106
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
K100468	Zeiss Infrared 800 with Flow 800 Option	Carl Zeiss Surgical GmbH	2010	4
K130003	Xiralite Flourescence Imaging System X4	Mivenion GmbH	2014	0

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.
6 of the 8 ancestors have a recall of any class.
Of its descendants, K091515 (Novadaq Technologies, Inc., 2009) has gone furthest, with 106 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 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K073088 · printed Nov 5, 2026

Cite this page

510(k) Report. “K073088: 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/K073088

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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