510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Spy Intra-Operative Imaging System: SP2000

K042961510(k) TraditionalCleared Jan 19, 200584-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 Jan 19, 2005 as substantially equivalent to K984545 (Philips Medical Systems North America, Inc., 1999) and 1 other predicate after an 84-day review. Its family tree reaches back 1 generation to 1994. 136 later devices descend from it. It has been recalled once.

Decided
Jan 19, 2005
Review
84 days
Class
Class II
Product code
IZI
Recalls
1
Predicates
2

Its longest line of descent runs back 1 generation to K944261 (1994). 2 ancestors in all. 136 later devices descend from it, 11 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor2008: 3 descendants cleared2007: 4 descendants cleared2014: 5 descendants cleared2006: 2 descendants cleared2010: 1 descendant cleared2011: 2 descendants cleared2009: 1 descendant cleared2017: 5 descendants cleared2015: 4 descendants cleared2012: 1 descendant cleared2019: 6 descendants cleared2024: 14 descendants cleared2023: 15 descendants cleared2021: 10 descendants cleared2016: 3 descendants cleared2018: 5 descendants cleared2022: 12 descendants cleared2020: 8 descendants cleared2025: 16 descendants cleared2013: 1 descendant cleared2026: 18 descendants clearedK944261 · Retina Angiograph · Heidelberg Engineering · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 11 descendants2 generations forward: 11 descendants3 generations forward: 13 descendants4 generations forward: 13 descendants5 generations forward: 28 descendants6 generations forward: 28 descendants7 generations forward: 20 descendants8 generations forward: 10 descendants9 generations forward: 2 descendants K944261 · Retina Angiograph · Heidelberg Engineering · 19940+5
  1. Root · 1 generation backK944261 Retina AngiographHeidelberg Engineering · 1994
  2. This deviceK042961 Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc. · 2005
  3. Descendant · cites it directly · 134 of its ownK060867 Spy Intraoperative Imaging SystemNovadaq Technologies, Inc. · 2006 · Recalled
  4. Descendant · cites it directly · 133 of its ownK061871 Leica Model FL800Leica Microsystems, Inc. · 2006
  5. Descendant · cites it directly · 131 of its ownK071037 Spy Intra-Operative Imaging System, Model SP2000Novadaq Technologies, Inc. · 2007 · Recalled
  6. Descendant · cites it directly · 131 of its ownK063345 Spy Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
  7. Descendant · cites it directly · 129 of its ownK072222 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled

Showing 5 of 136 descendants. See all descendants

Descendants cleared per year

2006: 22007: 42008: 32009: 12010: 12011: 22012: 12013: 12014: 52015: 42016: 32017: 52018: 52019: 62020: 82021: 102022: 122023: 152024: 142025: 162026: 18
2006high 18 (2026) · low 1 (2009)2026

Most influential descendants

Showing 5 of 136 · See all
  • K060867Spy Intraoperative Imaging SystemNovadaq Technologies, Inc. · 2006 · cites it directly134descendants
  • K061871Leica Model FL800Leica Microsystems, Inc. · 2006 · cites it directly133descendants
  • K071037Spy Intra-Operative Imaging System, Model SP2000Novadaq Technologies, Inc. · 2007 · cites it directly131descendants
  • K063345Spy Imaging SystemNovadaq Technologies, Inc. · 2007 · cites it directly131descendants
  • K072222Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2007 · cites it directly129descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K944261Retina AngiographHeidelberg Engineering1994—
0 (this device)K042961Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc.2005—
+1K060867Spy Intraoperative Imaging SystemNovadaq Technologies, Inc.20061
+1K061871Leica Model FL800Leica Microsystems, Inc.2006—
+1K071037Spy Intra-Operative Imaging System, Model SP2000Novadaq Technologies, Inc.20071
+1K063345Spy Imaging SystemNovadaq Technologies, Inc.20071
+1K072222Spy Fluorescent Imaging SystemNovadaq Technologies, Inc.20071

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200740
200830
200910
201010
201120
201210
201310
201450
201540
201630
201750
201850
201960
202080
2021100
2022120
2023150
2024140
2025160
2026180
FIG. 1 — Lineage of K042961, 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
*K984545Release 2 of Philips Integris Series (V5000, BV5000, H5000, BH5000, HM2000) Systems
Summary page 1
…icate Devices: '[he Novadaq SPYTM Intra-operative Imaging System: SP2000 is equivalent to two predicate devices. The Philips Integra Series 2 Systems (K984545) is an Angiographic X-Ray System intended for use in acquiring diagnostic quality images during cardiac, angiographic…
Philips Medical Systems North America, Inc.199917
*K944261Retina Angiograph
Summary page 1
…diagnostic quality images during cardiac, angiographic, vascular, neurovascular, and interventional applications. The Heidelberg Retinal Angiographic System (K944261) is also equivalent to the SPYTM system. The indication for use is to acquire images of the posterior segment of the…
Heidelberg Engineering1994—

Also cleared against K984545: 7 other devices →

What descends from it? (136)

See all 136

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

NumberDeviceApplicantDecidedDescendants
K060867Spy Intraoperative Imaging SystemNovadaq Technologies, Inc.2006134
K061871Leica Model FL800Leica Microsystems, Inc.2006133
K071037Spy Intra-Operative Imaging System, Model SP2000Novadaq Technologies, Inc.2007131
K063345Spy Imaging SystemNovadaq Technologies, Inc.2007131
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
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?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K060867 (Novadaq Technologies, Inc., 2006) has gone furthest, with 134 descendants of its own.
  • 7 other devices also cite its predicate K984545.

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.

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 intra-operative 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 K984545

7 other devices cite the same predicate.

  • K130842Allura Xper FD or Table Series; Allura Xper FD10 Series; Allura Xper FD20 Series; Allura Xper FD Biplane…Philips Medical Systems Nederland B.V. · 201311 Class I recalls
  • K070834CS-Series Fluoroscopy System, CS-10 Through CS-65 (11 Configurations)Omega Medical Imaging, Inc. · 2007
  • K062647E-View Fluoroscopy System, Model CS-50Omega Medical Imaging, Inc. · 2006
  • K041780New BridMedical Imaging Solutions, Inc. · 2004
  • K031836Philips Fresco Release 1Philips Medical Systems North America Co. · 2003
  • K020055Philips Integris Allura 9 with FD OptionPhilips Medical Systems · 20022 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/K042961 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042961: Spy Intra-Operative Imaging System: SP2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042961

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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