510(k) · Cleared
Recalled · Class II · 2016Spy 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 Jan 12, 2007 as substantially equivalent to K042961 (Novadaq Technologies, Inc., 2005) and 2 other predicates after a 67-day review. Its family tree reaches back 3 generations to 1994. 131 later devices descend from it. It has been recalled once.
- Decided
- Jan 12, 2007
- Review
- 67 days
- Class
- Class II
- Product code
- IZI
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K944261 (1994). 5 ancestors in all. 131 later devices descend from it, 8 citing it directly.
- Root · 3 generations backK944261 Retina AngiographHeidelberg Engineering · 1994
- 2 generations backK042961 Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc. · 2005 · Recalled
- 1 generation backK060867 Spy Intraoperative Imaging SystemNovadaq Technologies, Inc. · 2006 · Recalled
- This deviceK063345 Spy Imaging SystemNovadaq Technologies, Inc. · 2007
- Descendant · cites it directly · 129 of its ownK072222 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- Descendant · cites it directly · 119 of its ownK073088 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2008
- Descendant · 2 generations on · 106 of its ownK091515 Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 104 of its ownK101077 DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc. · 2011 · Recalled
- 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
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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944261 | Retina Angiograph | Heidelberg Engineering | 1994 | — |
| −2 | K042961 | Spy Intra-Operative Imaging System: SP2000 | Novadaq Technologies, Inc. | 2005 | 1 |
| −1 | K060867 | Spy Intraoperative Imaging System | Novadaq Technologies, Inc. | 2006 | 1 |
| 0 (this device) | K063345 | Spy Imaging System | Novadaq Technologies, Inc. | 2007 | — |
| +1 | K072222 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| +1 | K073088 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2008 | — |
| +2 | K091515 | Spy Scope Intra-Operative Operating System | Novadaq Technologies, Inc. | 2009 | 1 |
| +3 | K101077 | DA Vinci Fluorescence Imaging Vision System, Model FF 100 | Intuitive Surgical, Inc. | 2011 | 2 |
| +4 | K124031 | DA Vinci Fluorescence Imaging Vision System | Intuitive Surgical, Inc. | 2013 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 6 | 0 |
| 2020 | 8 | 0 |
| 2021 | 10 | 0 |
| 2022 | 12 | 0 |
| 2023 | 15 | 0 |
| 2024 | 14 | 0 |
| 2025 | 16 | 0 |
| 2026 | 18 | 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? (3)
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…pared: November 2, 2006 Legally Marketed Predicate Devices: The Novadaq® SPY Imaging System had received FDA 510(k) clearance for market in January 2005 (K#042961) and subsequently 510(k) clearance for a labeling change in May 2006 (K#060867). The Leica FL800 had received FDA 51… | 2005 |
| * | K060867 | Spy Intraoperative Imaging SystemSummary page 1…Imaging System had received FDA 510(k) clearance for market in January 2005 (K#042961) and subsequently 510(k) clearance for a labeling change in May 2006 (K#060867). The Leica FL800 had received FDA 510(k) clearance for market in September 2006 (K#061871). The Leica FL800 is inte… | 2006 |
| * | K061871 | Leica Model FL800Summary page 1…ently 510(k) clearance for a labeling change in May 2006 (K#060867). 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 Imagin… | 2006 |
What descends from it? (131)
See all 1318 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072222 | Spy Fluorescent Imaging System | 2007 | 129 |
| K073088 | Spy Fluorescent Imaging System | 2008 | 119 |
| K150018 | VS3-IR-MMS System | 2015 | 35 |
| K073130 | Spy Fluorescent Imaging System | 2008 | 20 |
| K100371 | Spy Intra-Operative Imaging System | 2011 | 16 |
| K110480 | Pde Photodynamic Eye | 2012 | 13 |
| K162885 | SPY Phi Open Field Handheld Fluorescence Imaging System | 2017 | 10 |
| K100468 | Zeiss Infrared 800 with Flow 800 Option | 2010 | 4 |
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. |
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 5 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 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 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/K063345 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063345: Spy Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063345
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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