510(k) · Cleared
ClearedVS3-Iridium System (VS3-IR)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visionsense, Ltd. · OWN Confocal Optical Imaging
Cleared on Oct 28, 2022 as substantially equivalent to K150018 (Visionsense, Ltd., 2015) and 4 other predicates after a 29-day review. Its family tree reaches back 20 generations to 1994.
- Decided
- Oct 28, 2022
- Review
- 29 days
- Class
- Class II
- Product code
- OWN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 20 generations to K930667 (1994). 108 ancestors in all, the oldest K811390 (1981). No later device cites it as a predicate yet.
- Root · 20 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 16 generations between
- 3 generations backK182606 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2018
- 2 generations backK191851 VS3-IRMedtronic · 2019
- 1 generation backK210265 VS3 Iridium SytemVisionsense, Ltd. · 2021
- This deviceK223020 VS3-Iridium System (VS3-IR)Visionsense, Ltd. · 2022
Show all 20 generations
- Root · 20 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 19 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 18 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 17 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 16 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 15 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- 14 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
- 13 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- 12 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 11 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- 10 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
- 9 generations backK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
- 8 generations backK123463 Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · Recalled
- 7 generations backK131861 DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · Recalled
- 6 generations backK141077 DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · Recalled
- 5 generations backK150956 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016 · Recalled
- 4 generations backK161792 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016
- 3 generations backK182606 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2018
- 2 generations backK191851 VS3-IRMedtronic · 2019
- 1 generation backK210265 VS3 Iridium SytemVisionsense, Ltd. · 2021
- This deviceK223020 VS3-Iridium System (VS3-IR)Visionsense, Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −19 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −18 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −17 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −16 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −15 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| −14 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
| −13 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| −12 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| −11 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
| −10 | K081137 | Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 | Intuitive Surgical, Inc. | 2009 | 25 |
| −9 | K090993 | Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200… | Intuitive Surgical, Inc. | 2009 | 3 |
| −8 | K123463 | Intuitive Surgical DA Vinci SI Surgical System Smartpedals | Intuitive Surgical, Inc. | 2012 | 2 |
| −7 | K131861 | DA Vinci Surgical System, Endowrist Instruments and Accessories | Intuitive Surgical, Inc. | 2014 | 80 |
| −6 | K141077 | DA Vinci Firefly Imaging System | Intuitive Surgical, Inc. | 2014 | 2 |
| −5 | K150956 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies, Inc. | 2016 | 1 |
| −4 | K161792 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies, Inc. | 2016 | — |
| −3 | K182606 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2018 | — |
| −2 | K191851 | VS3-IR | Medtronic | 2019 | — |
| −1 | K210265 | VS3 Iridium Sytem | Visionsense, Ltd. | 2021 | — |
| 0 (this device) | K223020 | VS3-Iridium System (VS3-IR) | Visionsense, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 2 | 0 |
| 1997 | 11 | 0 |
| 1998 | 4 | 0 |
| 1999 | 7 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2019 | 1 | 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? (5)
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 |
|---|---|---|---|
| * | K150018 | VS3-IR-MMS SystemSummary page 4…(972) 3-924-4335 Email: [email protected] 2. Subject Device Trade Name: VS3-Iridium System (VS3-IR) VS3-IR system Camera (K150018, K152204, K183453, K191851, K210265) configuration Laser Light Source (LLS) (K150018, K152204, K… | 2015 |
| * | K152204 | VS3-IR systemSummary page 4…24-4335 Email: [email protected] 2. Subject Device Trade Name: VS3-Iridium System (VS3-IR) VS3-IR system Camera (K150018, K152204, K183453, K191851, K210265) configuration Laser Light Source (LLS) (K150018, K152204, K183453, K… | 2015 |
| * | K183453 | VS3-IRSummary page 4…Email: [email protected] 2. Subject Device Trade Name: VS3-Iridium System (VS3-IR) VS3-IR system Camera (K150018, K152204, K183453, K191851, K210265) configuration Laser Light Source (LLS) (K150018, K152204, K183453, K191851, K… | 2019 |
| * | K191851 | VS3-IRSummary page 4…[email protected] 2. Subject Device Trade Name: VS3-Iridium System (VS3-IR) VS3-IR system Camera (K150018, K152204, K183453, K191851, K210265) configuration Laser Light Source (LLS) (K150018, K152204, K183453, K191851, K210265)… | 2019 |
| * | K210265 | VS3 Iridium SytemSummary page 4…[email protected] 2. Subject Device Trade Name: VS3-Iridium System (VS3-IR) VS3-IR system Camera (K150018, K152204, K183453, K191851, K210265) configuration Laser Light Source (LLS) (K150018, K152204, K183453, K191851, K210265)… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 28 of the 108 ancestors have a recall of any class.
- 1 other device also cites its predicate K150018.
How does its category compare?
All OWN devicesOWN Confocal Optical Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 VS3-Iridium System is intended to provide real-time visible and near infrared fluorescence imaging in both open and minimally invasive procedures. Upon intravenous administration and use of an ICG consistent with its approved labeling, the VS3-Iridium System is used to perform fluorescence imaging visualization of vessels, blood flow and tissue perfusion before during and after general minimally invasive surgical procedures and plastic, micro-…
Read the full statement (134 words)
The VS3-Iridium System is intended to provide real-time visible and near infrared fluorescence imaging in both open and minimally invasive procedures.
Upon intravenous administration and use of an ICG consistent with its approved labeling, the VS3-Iridium System is used to perform fluorescence imaging visualization of vessels, blood flow and tissue perfusion before during and after general minimally invasive surgical procedures and plastic, micro-, reconstructive surgeries.
Upon interstitial administration and use of ICG consistent with its approved labeling, the Endoscope configuration of the VS3-Iridium System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Upon administration and use of pafolacianine consistent with its approved labeling, the VS3-Iridium 785 nm System is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
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/K223020 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223020: VS3-Iridium System (VS3-IR).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223020
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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