510(k) · Cleared
ClearedSpy Intra-Operative 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 Feb 4, 2011 as substantially equivalent to K042961 (Novadaq Technologies, Inc., 2005) and 8 other predicates after a 357-day review. Its family tree reaches back 6 generations to 1994. 16 later devices descend from it.
- Decided
- Feb 4, 2011
- Review
- 357 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 6 generations to K944261 (1994). 21 ancestors in all, the oldest K860913 (1986). 16 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK944261 Retina AngiographHeidelberg Engineering · 1994
- 5 generations backK042961 Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc. · 2005 · Recalled
- 4 generations backK060867 Spy Intraoperative Imaging SystemNovadaq Technologies, Inc. · 2006 · Recalled
- 3 generations backK063345 Spy Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- 2 generations backK072222 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- 1 generation backK073088 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2008
- This deviceK100371 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 · cites it directly · 10 of its ownK162885 SPY Phi Open Field Handheld Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 9 of its ownK192174 SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2019
- Descendant · 3 generations on · 8 of its ownK200737 SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2020
- Descendant · 2 generations on · 5 of its ownK202244 SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker) · 2020
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K182907SPY Elite Intraoperative Perfusion Assessment SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2019 · cites it directly14descendants
- K162885SPY Phi Open Field Handheld Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2017 · cites it directly10descendants
- K192174SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2019 · 2 generations on9descendants
- K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2020 · 3 generations on8descendants
- K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker) · 2020 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K944261 | Retina Angiograph | Heidelberg Engineering | 1994 | — |
| −5 | K042961 | Spy Intra-Operative Imaging System: SP2000 | Novadaq Technologies, Inc. | 2005 | 1 |
| −4 | K060867 | Spy Intraoperative Imaging System | Novadaq Technologies, Inc. | 2006 | 1 |
| −3 | K063345 | Spy Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| −2 | K072222 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| −1 | K073088 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2008 | — |
| 0 (this device) | 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 | — |
| +1 | K162885 | SPY Phi Open Field Handheld Fluorescence Imaging System | Novadaq Technologies, Inc. | 2017 | 1 |
| +2 | K192174 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2019 | — |
| +3 | K200737 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2020 | — |
| +2 | K202244 | SPY-PHI System with SPY-PHI Fluorescence Assessment Software | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (9)
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…ood and Drug Administration (FDA) Premarket Notification 510(k) (510(k)) clearance for market for 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 to inject the imaging agent indocyanine gr… | 2005 |
| * | K060867 | Spy Intraoperative Imaging SystemSummary page 1…(510(k)) clearance for market for 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 to inject the imaging agent indocyanine green (ICG) directly into the graft, followed by a clearance for u… | 2006 |
| * | K063345 | Spy Imaging SystemSummary page 1…inject the imaging agent indocyanine green (ICG) directly into the graft, followed by a clearance for use in plastic, micro- and reconstructive surgery in January 2007 (K063345). Clearances for use of an alternative brand of fluorescent ICG agent in coronary artery bypass surgery and plastic, micro-, and… | 2007 |
| * | K071037 | Spy Intra-Operative Imaging System, Model SP2000Summary page 1…ces for use of an alternative brand of fluorescent ICG agent in coronary artery bypass surgery and plastic, micro-, and reconstructive surgery were obtained in May 2007 (K071037) and September 2007 (K072222), respectively. A labeling change to broaden the use of the SPY system in cardiovascular surgical pr… | 2007 |
| * | K072222 | Spy Fluorescent Imaging SystemSummary page 1…brand of fluorescent ICG agent in coronary artery bypass surgery and plastic, micro-, and reconstructive surgery were obtained in May 2007 (K071037) and September 2007 (K072222), respectively. A labeling change to broaden the use of the SPY system in cardiovascular surgical procedures, from the narrower i… | 2007 |
| * | K071619 | Spy Fluorescent Imaging SystemSummary page 1…ng change to broaden the use of the SPY system in cardiovascular surgical procedures, from the narrower indication for use in CABG surgery, was cleared in November 2007 (K071619). The SPY Intra-operative Imaging System, device model SP2001, was subsequently cleared for use in plastic, micro- and reconstru… | 2007 |
| * | K073088 | Spy Fluorescent Imaging SystemSummary page 1…(K071619). The SPY Intra-operative Imaging System, device model SP2001, was subsequently cleared for use in plastic, micro- and reconstructive surgery in January 2008 (K073088) and for organ transplant surgeries in January 2008 (K073130). Novadaq believes that the SPY System described in this applicatio… | 2008 |
| * | K073130 | Spy Fluorescent Imaging SystemSummary page 1…odel SP2001, was subsequently cleared for use in plastic, micro- and reconstructive surgery in January 2008 (K073088) and for organ transplant surgeries in January 2008 (K073130). Novadaq believes that the SPY System described in this application is also substantially equivalent to the previously cleared… | 2008 |
| * | K040675 | Axiom Artis USummary page 1…8 (K073130). Novadaq believes that the SPY System described in this application is also substantially equivalent to the previously cleared Siemens AXIOM Artis U system (K040675). Both systems share the same product code (90 |1Z1) and regulatory classification (21 CFR § 892.1600). The indications for use o… | 2004 |
What descends from it? (16)
See all 162 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)
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 17 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 15 of the 21 ancestors have a recall of any class.
- Of its descendants, K182907 (Novadaq Technologies Ulc. (Now A Part of Stryker), 2019) has gone furthest, with 14 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. 2011, 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 intended to provide fluorescence images for the visual assessment
of blood flow in vessels and related tissue perfusion during gastrointestinal surgical
procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K100371 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100371: Spy Intra-Operative 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/K100371
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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