510(k) · Cleared
Cleared780 nm SPY Portable Handheld Imaging (SPY-PHI) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · IZI System, X-Ray, Angiographic
Cleared on May 28, 2026 as substantially equivalent to K230727 (Novadaq Technologies Ulc (A Part of Stryker), 2023) and 1 other predicate after a 59-day review. Its family tree reaches back 25 generations to 1994. 3 of the 179 devices in its family, counting itself, have a Class I recall.
- Decided
- May 28, 2026
- Review
- 59 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 25 generations to K930667 (1994). 178 ancestors in all, the oldest K811390 (1981). No later device cites it as a predicate yet. 3 of the 179 devices in this family, counting this one, have a Class I recall.
- Root · 25 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 21 generations between
- 3 generations backK230216 1688 4K Camera Control Unit with Advanced Imaging Modality…Stryker · 2023
- 2 generations backK230605 1788 4K Camera System with Advanced Imaging ModalityStryker · 2023
- 1 generation backK231854 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light…Stryker · 2023
- This deviceK261037 780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy · 2026
Show all 25 generations
- Root · 25 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 24 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 23 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 22 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 21 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 20 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- 19 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
- 18 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- 17 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 16 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- 15 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
- 14 generations backK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
- 13 generations backK123463 Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · Recalled
- 12 generations backK131861 DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · Recalled
- 11 generations backK141077 DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · Recalled
- 10 generations backK150956 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016 · Recalled
- 9 generations backK161792 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016
- 8 generations backK182160 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688…Stryker · 2018 · Recalled
- 7 generations backK202592 Adavanced Imaging Modality System (1688 4K Camera System With…Stryker · 2020
- 6 generations backK210088 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight…Stryker · 2021
- 5 generations backK211202 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight…Stryker · 2021
- 4 generations backK214046 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM…Stryker · 2022
- 3 generations backK230216 1688 4K Camera Control Unit with Advanced Imaging Modality…Stryker · 2023
- 2 generations backK230605 1788 4K Camera System with Advanced Imaging ModalityStryker · 2023
- 1 generation backK231854 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light…Stryker · 2023
- This deviceK261037 780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −24 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −23 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −22 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −21 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −20 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| −19 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
| −18 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| −17 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| −16 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
| −15 | K081137 | Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 | Intuitive Surgical, Inc. | 2009 | 25 |
| −14 | K090993 | Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200… | Intuitive Surgical, Inc. | 2009 | 3 |
| −13 | K123463 | Intuitive Surgical DA Vinci SI Surgical System Smartpedals | Intuitive Surgical, Inc. | 2012 | 2 |
| −12 | K131861 | DA Vinci Surgical System, Endowrist Instruments and Accessories | Intuitive Surgical, Inc. | 2014 | 80 |
| −11 | K141077 | DA Vinci Firefly Imaging System | Intuitive Surgical, Inc. | 2014 | 2 |
| −10 | K150956 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies, Inc. | 2016 | 1 |
| −9 | K161792 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies, Inc. | 2016 | — |
| −8 | K182160 | 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K… | Stryker | 2018 | 1 |
| −7 | K202592 | Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging… | Stryker | 2020 | — |
| −6 | K210088 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM… | Stryker | 2021 | — |
| −5 | K211202 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable… | Stryker | 2021 | — |
| −4 | K214046 | 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and… | Stryker | 2022 | — |
| −3 | K230216 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) | Stryker | 2023 | — |
| −2 | K230605 | 1788 4K Camera System with Advanced Imaging Modality | Stryker | 2023 | — |
| −1 | K231854 | 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source… | Stryker | 2023 | — |
| 0 (this device) | K261037 | 780 nm SPY Portable Handheld Imaging (SPY-PHI) System | Stryker Endoscopy | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 7 | 1 |
| 1992 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 4 | 0 |
| 1995 | 9 | 0 |
| 1996 | 5 | 0 |
| 1997 | 13 | 0 |
| 1998 | 6 | 0 |
| 1999 | 8 | 0 |
| 2000 | 5 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 4 | 1 |
| 2004 | 5 | 0 |
| 2005 | 6 | 0 |
| 2006 | 8 | 1 |
| 2007 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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.
3 devices in this family have a Class I recall. 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K230727 | SPY Portable Handheld Imaging (SPY-PHI) SystemSummary page 5…equent Product Code IZI 510(k) Review Panel Radiology Predicate Device: Primary Predicate Device SPY Portable Handheld Imaging (SPY-PHI) K230727 System Secondary Predicate Device 1788 4K Advanced Imaging Modality (AIM) K231854… | 2023 |
| * | K231854 | 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMSummary page 5…Portable Handheld Imaging (SPY-PHI) K230727 System Secondary Predicate Device 1788 4K Advanced Imaging Modality (AIM) K231854 Platform Reference Device Medtronic VS3-Iridium System (VS3-IR) K210265,… | 2023 |
| † | K210265 | VS3 Iridium Sytem | 2021 |
| † | K223020 | VS3-Iridium System (VS3-IR) | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 3 generations back · ◆ in the 2006 ancestors bar of FIG. 16 Class I recalls
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 5 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 57 of the 178 ancestors have a recall of any class; 3 have a Class I recall.
- 3 other devices also cite its predicate K230727.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the 780 nm SPY-PHI System is used with SPY AGENT GREEN to perform intraoperative fluorescence angiography. The 780 nm SPY-PHI System is indicated for use in adult and pediatric patients one month of age and older. The 780 nm SPY-PHI System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after: vascular, gastrointestinal…
Read the full statement (184 words)
Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the 780 nm SPY-PHI System is used with SPY AGENT GREEN to perform intraoperative fluorescence angiography. The 780 nm SPY-PHI System is indicated for use in adult and pediatric patients one month of age and older.
The 780 nm SPY-PHI System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after: vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgical procedures.
Upon interstitial administration of SPY AGENT GREEN, the 780 nm SPY-PHI System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Upon intradermal administration of SPY AGENT GREEN, the 780 nm SPY-PHI System is indicated for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in adults with breast cancer for which this procedure is a component of intraoperative management.
Upon administration and use of pafolacianine consistent with its approved label, the 780 nm SPY-PHI System is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261037 · printed Nov 4, 2026
Cite this page
510(k) Report. “K261037: 780 nm SPY Portable Handheld Imaging (SPY-PHI) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K261037
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026