510(k) · Cleared
Recalled · Class II · 2020SPY Phi Open Field Handheld Fluorescence Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novadaq Technologies, Inc. · OWN Confocal Optical Imaging
Cleared on Jan 11, 2017 as substantially equivalent to K133719 (Hamamatsu Photonics K.K., 2014) and 3 other predicates after an 86-day review. Its family tree reaches back 8 generations to 1994. 10 later devices descend from it. It has been recalled once.
- Decided
- Jan 11, 2017
- Review
- 86 days
- Class
- Class II
- Product code
- OWN
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 8 generations to K944261 (1994). 25 ancestors in all, the oldest K860913 (1986). 10 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK944261 Retina AngiographHeidelberg Engineering · 1994
- 7 generations backK042961 Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc. · 2005 · Recalled
- 6 generations backK060867 Spy Intraoperative Imaging SystemNovadaq Technologies, Inc. · 2006 · Recalled
- 5 generations backK063345 Spy Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- 4 generations backK072222 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- 3 generations backK073130 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2008
- 2 generations backK110480 Pde Photodynamic EyeHamamatsu Photonics K.K. · 2012
- 1 generation backK133719 Pde-NeoHamamatsu Photonics K.K. · 2014
- This deviceK162885 SPY Phi Open Field Handheld Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2017
- Descendant · cites it directly · 9 of its ownK192174 SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2019
- Descendant · 2 generations on · 8 of its ownK200737 SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2020
- Descendant · 3 generations on · 5 of its ownK202244 SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker) · 2020
- Descendant · 3 generations on · 4 of its ownK230727 SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker) · 2023
- Descendant · 4 generations on · 0 of its ownK261037 780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K192174SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2019 · cites it directly9descendants
- K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2020 · 2 generations on8descendants
- K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker) · 2020 · 3 generations on5descendants
- K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker) · 2023 · 3 generations on4descendants
- K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K944261 | Retina Angiograph | Heidelberg Engineering | 1994 | — |
| −7 | K042961 | Spy Intra-Operative Imaging System: SP2000 | Novadaq Technologies, Inc. | 2005 | 1 |
| −6 | K060867 | Spy Intraoperative Imaging System | Novadaq Technologies, Inc. | 2006 | 1 |
| −5 | K063345 | Spy Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| −4 | K072222 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| −3 | K073130 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2008 | — |
| −2 | K110480 | Pde Photodynamic Eye | Hamamatsu Photonics K.K. | 2012 | — |
| −1 | K133719 | Pde-Neo | Hamamatsu Photonics K.K. | 2014 | — |
| 0 (this device) | K162885 | SPY Phi Open Field Handheld Fluorescence Imaging System | Novadaq Technologies, Inc. | 2017 | — |
| +1 | K192174 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2019 | — |
| +2 | K200737 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2020 | — |
| +3 | K202244 | SPY-PHI System with SPY-PHI Fluorescence Assessment Software | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2020 | — |
| +3 | K230727 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc (A Part of Stryker) | 2023 | — |
| +4 | 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 |
|---|---|---|
| 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 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 24.9 · 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? (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 |
|---|---|---|---|
| * | K133719 | Pde-NeoSummary page 6…f operation, intended use, environment of use, and indications for use, SPY PHI has been determined to be substantially equivalent to the predicate devices, the PDE-Neo (K133719), Fluobeam 800 Clinic® Imaging Device with Fluocase 800™ control system (K132475), and the SPY Intra- operative Imaging System (K… | 2014 |
| * | K132475 | Fluobeam 800 Clinic Laser Imaging Device and Fluocase 800 Control SystemSummary page 6…as been determined to be substantially equivalent to the predicate devices, the PDE-Neo (K133719), Fluobeam 800 Clinic® Imaging Device with Fluocase 800™ control system (K132475), and the SPY Intra- operative Imaging System (K063345 and K100371). Any technological and design differences between SPY PHI and… | 2014 |
| * | K063345 | Spy Imaging SystemSummary page 4…maging System Product Code/Regulation: OWN/21 CFR 876.1500 Classification: Class II Device Trade Name: SPY Imaging System (SP2000) – K063345; SPY Intra-operative Imaging System (SP2001) - K100371 Submitter Name: Novadaq Te… | 2007 |
| * | K100371 | Spy Intra-Operative Imaging SystemSummary page 4…Class II Device Trade Name: SPY Imaging System (SP2000) – K063345; SPY Intra-operative Imaging System (SP2001) - K100371 Submitter Name: Novadaq Technologies Inc. Device Common Name: Fluorescence Angiographic System Produc… | 2011 |
| † | K150956 | PINPOINT Endoscopic Fluorescence Imaging System | 2016 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192174 | SPY Portable Handheld Imaging (SPY-PHI) System | 2019 | 9 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 7, 2020 | Class II | Z-1925-2020 | Under Investigation by firm | Sterile drapes packaged in an unsealed pouch. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 15 of the 25 ancestors have a recall of any class.
- Of its descendants, K192174 (Novadaq Technologies Ulc. (Now A Part of Stryker), 2019) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K133719.
How does its category compare?
All OWN devicesOWN Confocal Optical Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
The SPY Phi Open Field Handheld Fluorescence Imaging System is an imaging system used in capturing and viewing fluorescence 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.
The SPY Phi Open Field Handheld Fluorescence Imaging 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/K162885 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162885: SPY Phi Open Field Handheld Fluorescence 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/K162885
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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