510(k) · Cleared
ClearedPde-Neo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hamamatsu Photonics K.K. · IZI System, X-Ray, Angiographic
Cleared on Mar 27, 2014 as substantially equivalent to K110480 (Hamamatsu Photonics K.K., 2012) after a 112-day review. Its family tree reaches back 7 generations to 1994. 11 later devices descend from it.
- Decided
- Mar 27, 2014
- Review
- 112 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K944261 (1994). 11 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK944261 Retina AngiographHeidelberg Engineering · 1994
- 6 generations backK042961 Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc. · 2005 · Recalled
- 5 generations backK060867 Spy Intraoperative Imaging SystemNovadaq Technologies, Inc. · 2006 · Recalled
- 4 generations backK063345 Spy Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- 3 generations backK072222 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- 2 generations backK073130 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2008
- 1 generation backK110480 Pde Photodynamic EyeHamamatsu Photonics K.K. · 2012
- This deviceK133719 Pde-NeoHamamatsu Photonics K.K. · 2014
- 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 · 4 generations on · 5 of its ownK202244 SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker) · 2020
- Descendant · 4 generations on · 4 of its ownK230727 SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker) · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- 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 · 4 generations on5descendants
- K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker) · 2023 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K944261 | Retina Angiograph | Heidelberg Engineering | 1994 | — |
| −6 | K042961 | Spy Intra-Operative Imaging System: SP2000 | Novadaq Technologies, Inc. | 2005 | 1 |
| −5 | K060867 | Spy Intraoperative Imaging System | Novadaq Technologies, Inc. | 2006 | 1 |
| −4 | K063345 | Spy Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| −3 | K072222 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| −2 | K073130 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2008 | — |
| −1 | K110480 | Pde Photodynamic Eye | Hamamatsu Photonics K.K. | 2012 | — |
| 0 (this device) | K133719 | Pde-Neo | Hamamatsu Photonics K.K. | 2014 | — |
| +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 | — |
| +4 | K202244 | SPY-PHI System with SPY-PHI Fluorescence Assessment Software | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2020 | — |
| +4 | K230727 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc (A Part of Stryker) | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 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 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? (1)
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 |
|---|---|---|---|
| * | K110480 | Pde Photodynamic Eye | 2012 |
What descends from it? (11)
See all 112 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 20 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 11 ancestors have a recall of any class.
- Of its descendants, K162885 (Novadaq Technologies, Inc., 2017) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K110480.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Pde-neo 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 during plastic, micro-, reconstructive, and organ transplant surgeries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133719: Pde-Neo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133719
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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