510(k) · Cleared
ClearedSPY Portable Handheld Imaging (SPY-PHI) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novadaq Technologies Ulc. (Now A Part of Stryker) · OWN Confocal Optical Imaging
Cleared on Nov 15, 2019 as substantially equivalent to K190729 (Novadaq Technologies Ulc. (Now A Part of Stryker), 2019) and 2 other predicates after a 95-day review. Its family tree reaches back 9 generations to 1994. 9 later devices descend from it.
- Decided
- Nov 15, 2019
- Review
- 95 days
- Class
- Class II
- Product code
- OWN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K944261 (1994). 28 ancestors in all, the oldest K860913 (1986). 9 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK944261 Retina AngiographHeidelberg Engineering · 1994
- 5 generations between
- 3 generations backK110480 Pde Photodynamic EyeHamamatsu Photonics K.K. · 2012
- 2 generations backK133719 Pde-NeoHamamatsu Photonics K.K. · 2014
- 1 generation backK162885 SPY Phi Open Field Handheld Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2017 · Recalled
- This deviceK192174 SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2019
- Descendant · cites it directly · 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
- Descendant · 2 generations on · 4 of its ownK230727 SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker) · 2023
- Descendant · 3 generations on · 0 of its ownK261037 780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy · 2026
- Descendant · 3 generations on · 0 of its ownK253181 SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation · 2026
Show all 9 generations
- Root · 9 generations backK944261 Retina AngiographHeidelberg Engineering · 1994
- 8 generations backK042961 Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc. · 2005 · Recalled
- 7 generations backK060867 Spy Intraoperative Imaging SystemNovadaq Technologies, Inc. · 2006 · Recalled
- 6 generations backK063345 Spy Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- 5 generations backK072222 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- 4 generations backK073130 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2008
- 3 generations backK110480 Pde Photodynamic EyeHamamatsu Photonics K.K. · 2012
- 2 generations backK133719 Pde-NeoHamamatsu Photonics K.K. · 2014
- 1 generation backK162885 SPY Phi Open Field Handheld Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2017 · Recalled
- This deviceK192174 SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2019
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2020 · cites it directly8descendants
- K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker) · 2020 · 2 generations on5descendants
- K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker) · 2023 · 2 generations on4descendants
- K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy · 2026 · 3 generations on0descendants
- K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K944261 | Retina Angiograph | Heidelberg Engineering | 1994 | — |
| −8 | K042961 | Spy Intra-Operative Imaging System: SP2000 | Novadaq Technologies, Inc. | 2005 | 1 |
| −7 | K060867 | Spy Intraoperative Imaging System | Novadaq Technologies, Inc. | 2006 | 1 |
| −6 | K063345 | Spy Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| −5 | K072222 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| −4 | K073130 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2008 | — |
| −3 | K110480 | Pde Photodynamic Eye | Hamamatsu Photonics K.K. | 2012 | — |
| −2 | K133719 | Pde-Neo | Hamamatsu Photonics K.K. | 2014 | — |
| −1 | K162885 | SPY Phi Open Field Handheld Fluorescence Imaging System | Novadaq Technologies, Inc. | 2017 | 1 |
| 0 (this device) | K192174 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2019 | — |
| +1 | 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 | — |
| +2 | K230727 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc (A Part of Stryker) | 2023 | — |
| +3 | K261037 | 780 nm SPY Portable Handheld Imaging (SPY-PHI) System | Stryker Endoscopy | 2026 | — |
| +3 | K253181 | SURGIMAGE SIM 1000H Fluorescence Imaging Platform | Surgimage Corporation | 2026 | — |
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 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2023 | 2 | 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 OWN? 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 OWN device
- #1 K231854 1788 4K Camera System with Advanced Imaging…score 25.0 · 24 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 |
|---|---|---|---|
| * | K190729 | SPY Portable Handheld Imaging (SPY-PHI) SystemSummary page 4…ging SPY Elite Intraoperative (SPY-PHI) System Perfusion Assessment System 510(k) Number K190729; K162885 K182907 Submitter/510(k) Holder Name Novadaq Technologies ULC. Novadaq Technologies UL… | 2019 |
| * | K162885 | SPY Phi Open Field Handheld Fluorescence Imaging SystemSummary page 4…SPY Elite Intraoperative (SPY-PHI) System Perfusion Assessment System 510(k) Number K190729; K162885 K182907 Submitter/510(k) Holder Name Novadaq Technologies ULC. Novadaq Technologies ULC.… | 2017 |
| * | K182907 | SPY Elite Intraoperative Perfusion Assessment SystemSummary page 4…(SPY-PHI) System Perfusion Assessment System 510(k) Number K190729; K162885 K182907 Submitter/510(k) Holder Name Novadaq Technologies ULC. Novadaq Technologies ULC.… | 2019 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200737 | SPY Portable Handheld Imaging (SPY-PHI) System | 2020 | 8 |
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 25 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 16 of the 28 ancestors have a recall of any class.
- Of its descendants, K200737 (Novadaq Technologies Ulc. (Now A Part of Stryker), 2020) has gone furthest, with 8 descendants of its own.
How does its category compare?
All OWN devicesOWN Confocal Optical Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OWN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWN
196in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWN
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWN
197in 2025
MAUDE reports naming product code OWN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 3 | 87 | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 5 | 208 | 0 | 0 |
| 2015 | 5 | 163 | 0 | 1 |
| 2016 | 2 | — | 0 | 4 |
| 2017 | 5 | 87 | 0 | 12 |
| 2018 | 1 | — | 0 | 11 |
| 2019 | 7 | 81 | 0 | 59 |
| 2020 | 7 | 81 | 0 | 105 |
| 2021 | 4 | 104 | 0 | 312 |
| 2022 | 4 | 41 | 3 | 346 |
| 2023 | 6 | 69 | 0 | 164 |
| 2024 | 1 | — | 1 | 165 |
| 2025 | 3 | 196 | 0 | 197 |
| 2026 | 7 | 63 | 0 | — |
What is it indicated for?
Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP) the SPY-PHI System is used with SPY AGENT™ GREEN to perform intraoperative fluorescence angiography. The SPY-PHI System is indicated for use in adult and pediatric patients one month of age and older.
The 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192174 · printed Nov 3, 2026
Cite this page
510(k) Report. “K192174: SPY Portable Handheld Imaging (SPY-PHI) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K192174
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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