510(k) · Cleared
Recalled · Class II · 2016Spy Fluorescent Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novadaq Technologies, Inc. · IZI System, X-Ray, Angiographic
Cleared on Nov 9, 2007 as substantially equivalent to K042961 (Novadaq Technologies, Inc., 2005) and 3 other predicates after a 149-day review. Its family tree reaches back 4 generations to 1994. 26 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 9, 2007
- Review
- 149 days
- Class
- Class II
- Product code
- IZI
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 4 generations to K944261 (1994). 6 ancestors in all. 26 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK944261 Retina AngiographHeidelberg Engineering · 1994
- 3 generations backK042961 Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc. · 2005 · Recalled
- 2 generations backK060867 Spy Intraoperative Imaging SystemNovadaq Technologies, Inc. · 2006 · Recalled
- 1 generation backK071037 Spy Intra-Operative Imaging System, Model SP2000Novadaq Technologies, Inc. · 2007 · Recalled
- This deviceK071619 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2007
- Descendant · cites it directly · 20 of its ownK073130 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 · 2 generations on · 13 of its ownK110480 Pde Photodynamic EyeHamamatsu Photonics K.K. · 2012
- Descendant · 3 generations on · 11 of its ownK133719 Pde-NeoHamamatsu Photonics K.K. · 2014
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K073130Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2008 · cites it directly20descendants
- 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 · 2 generations on13descendants
- K133719Pde-NeoHamamatsu Photonics K.K. · 2014 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944261 | Retina Angiograph | Heidelberg Engineering | 1994 | — |
| −3 | K042961 | Spy Intra-Operative Imaging System: SP2000 | Novadaq Technologies, Inc. | 2005 | 1 |
| −2 | K060867 | Spy Intraoperative Imaging System | Novadaq Technologies, Inc. | 2006 | 1 |
| −1 | K071037 | Spy Intra-Operative Imaging System, Model SP2000 | Novadaq Technologies, Inc. | 2007 | 1 |
| 0 (this device) | K071619 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2007 | — |
| +1 | 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 | — |
| +2 | K110480 | Pde Photodynamic Eye | Hamamatsu Photonics K.K. | 2012 | — |
| +3 | K133719 | Pde-Neo | Hamamatsu Photonics K.K. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 0 |
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
What was it cleared against? (4)
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 | Decided |
|---|---|---|---|
| * | K042961 | Spy Intra-Operative Imaging System: SP2000Summary page 1…gally Marketed Predicate Devices: The Novadaq® SPY Fluorescent Imaging System (SPY System) had received FDA 510(k) clearance for market in January 2005 (K#042961), subsequent 510(k) clearances for a labeling change in May 2006 (K#060867) and use of an alternative brand of fluo… | 2005 |
| * | K060867 | Spy Intraoperative Imaging SystemSummary page 1…Y System) had received FDA 510(k) clearance for market in January 2005 (K#042961), subsequent 510(k) clearances for a labeling change in May 2006 (K#060867) and use of an alternative brand of fluorescent dye in May 2007, pending drug approval (K#071037). The Leica FL800… | 2006 |
| * | K071037 | Spy Intra-Operative Imaging System, Model SP2000Summary page 1…ent 510(k) clearances for a labeling change in May 2006 (K#060867) and use of an alternative brand of fluorescent dye in May 2007, pending drug approval (K#071037). The Leica FL800 had received FDA 510(k) clearance for market in September 2006 (K#061871). The Leica FL800 is in… | 2007 |
| * | K061871 | Leica Model FL800Summary page 1…of fluorescent dye in May 2007, pending drug approval (K#071037). The Leica FL800 had received FDA 510(k) clearance for market in September 2006 (K#061871). The Leica FL800 is intended for use to allow neurosurgeons to view blood flow. Device Description: The SPY Imagi… | 2006 |
What descends from it? (26)
See all 264 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 18, 2016 | Class II | Z-2767-2016 | Packaging | Novadaq is informing SK6000 PAQ users that a pinhole through the drape pouch film material was identified in some SK6000 PAQs during shipping validation testing. |
| Nov 4, 2014 | Class III | Z-0470-2015 | Error in labeling | Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label. |
| Nov 4, 2014 | Class III | Z-0469-2015 | Error in labeling | Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label. |
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.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K073130 (Novadaq Technologies, Inc., 2008) has gone furthest, with 20 descendants of its own.
- 10 other devices also cite its predicate K042961.
How does its category compare?
All IZI devicesIZI 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
2026 to Oct 25, outlined.
Median 510(k) review, days · IZI
81in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZI
2,171in 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 provide fluorescent images
for the visual assessment of blood flow in vessels and related tissue perfusion
during cardiovascular surgical procedures,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071619 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071619: 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/K071619
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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