510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Spy Intra-Operative Imaging System, Model SP2000

K071037510(k) SpecialCleared May 10, 200728-day reviewClass II21 CFR 892.1600Recalls 1

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 May 10, 2007 as substantially equivalent to K042961 (Novadaq Technologies, Inc., 2005) and 1 other predicate after a 28-day review. Its family tree reaches back 3 generations to 1994. 131 later devices descend from it. It has been recalled once.

Decided
May 10, 2007
Review
28 days
Class
Class II
Product code
IZI
Recalls
1
Predicates
2

Its longest line of descent runs back 3 generations to K944261 (1994). 4 ancestors in all. 131 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor2008: 3 descendants cleared2007: 2 descendants cleared2010: 1 descendant cleared2011: 2 descendants cleared2019: 6 descendants cleared2014: 5 descendants cleared2009: 1 descendant cleared2012: 1 descendant cleared2017: 5 descendants cleared2024: 14 descendants cleared2023: 15 descendants cleared2021: 10 descendants cleared2016: 3 descendants cleared2015: 3 descendants cleared2018: 5 descendants cleared2020: 8 descendants cleared2022: 12 descendants cleared2025: 16 descendants cleared2013: 1 descendant cleared2026: 18 descendants clearedK944261 · Retina Angiograph · Heidelberg Engineering · 1994K042961 · Spy Intra-Operative Imaging System: SP2000 · Novadaq Technologies, Inc. · 2005 · recalledK060867 · Spy Intraoperative Imaging System · Novadaq Technologies, Inc. · 2006 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 7 descendants2 generations forward: 10 descendants3 generations forward: 12 descendants4 generations forward: 14 descendants5 generations forward: 28 descendants6 generations forward: 28 descendants7 generations forward: 20 descendants8 generations forward: 10 descendants9 generations forward: 2 descendants K060867 · Spy Intraoperative Imaging System · Novadaq Technologies, Inc. · 2006 · recalledK042961 · Spy Intra-Operative Imaging System: SP2000 · Novadaq Technologies, Inc. · 2005 · recalledK944261 · Retina Angiograph · Heidelberg Engineering · 19940+5
  1. Root · 3 generations backK944261 Retina AngiographHeidelberg Engineering · 1994
  2. 2 generations backK042961 Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc. · 2005 · Recalled
  3. 1 generation backK060867 Spy Intraoperative Imaging SystemNovadaq Technologies, Inc. · 2006 · Recalled
  4. This deviceK071037 Spy Intra-Operative Imaging System, Model SP2000Novadaq Technologies, Inc. · 2007
  5. Descendant · cites it directly · 129 of its ownK072222 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
  6. Descendant · cites it directly · 119 of its ownK073088 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2008
  7. Descendant · 2 generations on · 106 of its ownK091515 Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc. · 2009 · Recalled
  8. Descendant · 3 generations on · 104 of its ownK101077 DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc. · 2011 · Recalled
  9. Descendant · 4 generations on · 103 of its ownK124031 DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc. · 2013

Showing 5 of 131 descendants. See all descendants

Descendants cleared per year

2007: 22008: 32009: 12010: 12011: 22012: 12013: 12014: 52015: 32016: 32017: 52018: 52019: 62020: 82021: 102022: 122023: 152024: 142025: 162026: 18
2007high 18 (2026) · low 1 (2009)2026

Most influential descendants

Showing 5 of 131 · See all
  • K072222Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2007 · cites it directly129descendants
  • K073088Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2008 · cites it directly119descendants
  • K091515Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc. · 2009 · 2 generations on106descendants
  • K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc. · 2011 · 3 generations on104descendants
  • K124031DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc. · 2013 · 4 generations on103descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K944261Retina AngiographHeidelberg Engineering1994—
−2K042961Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc.20051
−1K060867Spy Intraoperative Imaging SystemNovadaq Technologies, Inc.20061
0 (this device)K071037Spy Intra-Operative Imaging System, Model SP2000Novadaq Technologies, Inc.2007—
+1K072222Spy Fluorescent Imaging SystemNovadaq Technologies, Inc.20071
+1K073088Spy Fluorescent Imaging SystemNovadaq Technologies, Inc.2008—
+2K091515Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc.20091
+3K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc.20112
+4K124031DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
200830
200910
201010
201120
201210
201310
201450
201530
201630
201750
201850
201960
202080
2021100
2022120
2023150
2024140
2025160
2026180
FIG. 1 — Lineage of K071037, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K230727 SPY Portable Handheld Imaging (SPY-PHI) Systemscore 23.2 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K042961Spy Intra-Operative Imaging System: SP2000
Summary page 1
…ry Prepared: April 9, 2007 Legally Marketed Predicate Devices: The Novadaq SPY Imaging System had received FDA 510(k) clearance for market in January 2005 (K042961) and subsequently received 510(k) clearance for a labeling change in May 2006 (K060867). Device Description: The SP…
Novadaq Technologies, Inc.20051
*K060867Spy Intraoperative Imaging System
Summary page 1
…g System had received FDA 510(k) clearance for market in January 2005 (K042961) and subsequently received 510(k) clearance for a labeling change in May 2006 (K060867). Device Description: The SPY Imaging System: SP2000 is currently cleared for use for intra- operative visual asses…
Novadaq Technologies, Inc.20061

Also cleared against K042961: 10 other devices →

What descends from it? (131)

See all 131

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

NumberDeviceApplicantDecidedDescendants
K072222Spy Fluorescent Imaging SystemNovadaq Technologies, Inc.2007129
K073088Spy Fluorescent Imaging SystemNovadaq Technologies, Inc.2008119
K071619Spy Fluorescent Imaging SystemNovadaq Technologies, Inc.200726
K073130Spy Fluorescent Imaging SystemNovadaq Technologies, Inc.200820
K100371Spy Intra-Operative Imaging SystemNovadaq Technologies, Inc.201116
K080612Leica FL800Leica Microsystems (Schweiz) AG20089
K100468Zeiss Infrared 800 with Flow 800 OptionCarl Zeiss Surgical GmbH20104

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 18, 2016Class IIZ-2767-2016PackagingNovadaq is informing SK6000 PAQ users that a pinhole through the drape pouch film material was identified in some SK6000 PAQs during shipping validation testing.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
  • 3 of the 4 ancestors have a recall of any class.
  • Of its descendants, K072222 (Novadaq Technologies, Inc., 2007) has gone furthest, with 129 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. 2007, this device’s year, is highlighted.

FDA decisions per year · IZI

2in 2025

2007: 72008: 62009: 22010: 22011: 42012: 12013: 12014: 42016: 12017: 22018: 22019: 22020: 12021: 12022: 12023: 32024: 22025: 22026 (partial year): 2
2007high 7 (2007) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IZI

81in 2023

2007: 28 days median2008: 68 days median2011: 104 days median2014: 111 days median2023: 81 days median
2007high 111 (2014) · low 28 (2007)2026

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

Recalls per year · IZI

1in 2021

2007: 62008: 522009: 182010: 112011: 62012: 62013: 62014: 52015: 142016: 72017: 12018: 22019: 22020: 22021: 12026 (partial year): 1
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

2007: 922008: 1012009: 1322010: 2522011: 3772012: 772013: 582014: 1232015: 362016: 1022017: 882018: 492019: 302020: 142021: 292022: 2652023: 1,2042024: 1,3322025: 2,171
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007728692
200866852101
20092—18132
20102—11252
201141046377
20121—677
20131—658
201441115123
20150—1436
20161—7102
20172—188
20182—249
20192—230
20201—214
20211—129
20221—0265
202338101,204
20242—01,332
20252—02,171
20262—1—

What is it indicated for?

For use in intraoperative visual assessment of the coronary vasculature and

bypass grafts during coronary artery bypass (CABG) surgery.

Indications for use as stated in the FDA summary.

Also cleared against K042961

10 other devices cite the same predicate.

  • K130003Xiralite Flourescence Imaging System X4Mivenion GmbH · 2014
  • K100371Spy Intra-Operative Imaging SystemNovadaq Technologies, Inc. · 2011
  • K100468Zeiss Infrared 800 with Flow 800 OptionCarl Zeiss Surgical GmbH · 2010
  • K073088Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2008
  • K073130Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2008
  • K071619Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 20073 recalls

More from Novadaq Technologies, Inc.

20 FDA decisions under this applicant name. See the company

  • K162885SPY Phi Open Field Handheld Fluorescence Imaging SystemNovadaq Technologies, Inc. · 20171 recall
  • K161792PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016
  • K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 20161 recall
  • K123013Endoscopic IntroducerNovadaq Technologies, Inc. · 2013
  • P950042/S007Pinpoint Endoscopic Light Source and Video CameraNovadaq Technologies, Inc. · 2012

Recent decisions in IZI

The IZI category page

  • K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy · 2026
  • K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation · 2026
  • K243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbH · 2025
  • K243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) · 2025
  • K231986Modus IRSynaptive Medical, Inc. · 2024

https://510kreport.com/device/K071037 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071037: Spy Intra-Operative Imaging System, Model SP2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071037

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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