510(k) · Cleared
ClearedVS3-IR system
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, 2015 as substantially equivalent to K091515 (Novadaq Technologies, Inc., 2009) and 4 other predicates after an 83-day review. Its family tree reaches back 7 generations to 1994. 34 later devices descend from it.
- Decided
- Oct 28, 2015
- Review
- 83 days
- Class
- Class II
- Product code
- OWN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K944261 (1994). 41 ancestors in all, the oldest K910132 (1991). 34 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 backK073088 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2008
- 1 generation backK091515 Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc. · 2009 · Recalled
- This deviceK152204 VS3-IR systemVisionsense, Ltd. · 2015
- Descendant · cites it directly · 32 of its ownK162882 KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017
- Descendant · 2 generations on · 31 of its ownK171238 KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017
- Descendant · 2 generations on · 30 of its ownK180146 KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc. · 2018
- Descendant · 3 generations on · 19 of its ownK211202 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight…Stryker · 2021
- Descendant · 4 generations on · 14 of its ownK214046 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM…Stryker · 2022
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017 · cites it directly32descendants
- K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017 · 2 generations on31descendants
- K180146KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc. · 2018 · 2 generations on30descendants
- K2112021688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S…Stryker · 2021 · 3 generations on19descendants
- K214046780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight CableStryker · 2022 · 4 generations on14descendants
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 | K073088 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2008 | — |
| −1 | K091515 | Spy Scope Intra-Operative Operating System | Novadaq Technologies, Inc. | 2009 | 1 |
| 0 (this device) | K152204 | VS3-IR system | Visionsense, Ltd. | 2015 | — |
| +1 | K162882 | KARL STORZ ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | 2017 | — |
| +2 | K171238 | KARL STORZ ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | 2017 | — |
| +2 | K180146 | KARL STORZ ICG Imaging System | Karl Storz Endoscopy America, Inc. | 2018 | — |
| +3 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 8 | 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 |
|---|---|---|---|
| * | K091515 | Spy Scope Intra-Operative Operating SystemSummary page 4…cation Name Endoscopes and Accessories / Infrared Microscope-Endoscope / Angiographic X-ray System Predicate Device Novadaq Technologies SPY Imaging System (K063345 / K091515) Intended Use / Indications for Use The 3D Endoscope Module of the VS3-IR System is intended for viewing internal surgical site… | 2009 |
| * | K123467 | VS3Summary page 5…K152204 Page 2 of 5 Principles of Operation / Conditions of Use The VS3-IR System is made up of the following components: • VS3 3D Endoscope (K123467, K141002, K131434) • VS3-IR-MMS & ICG Kit (K150018) • VS3-IR-Endoscope & ICG Kit (not yet assigned). The following ta… | 2013 |
| * | K141002 | VS3 Stereoscopic High Definition Vision SystemSummary page 5…K152204 Page 2 of 5 Principles of Operation / Conditions of Use The VS3-IR System is made up of the following components: • VS3 3D Endoscope (K123467, K141002, K131434) • VS3-IR-MMS & ICG Kit (K150018) • VS3-IR-Endoscope & ICG Kit (not yet assigned). The following table summa… | 2014 |
| * | K131434 | VS3 Stereoscopic High Definition Vision SystemSummary page 5…K152204 Page 2 of 5 Principles of Operation / Conditions of Use The VS3-IR System is made up of the following components: • VS3 3D Endoscope (K123467, K141002, K131434) • VS3-IR-MMS & ICG Kit (K150018) • VS3-IR-Endoscope & ICG Kit (not yet assigned). The following table summarizes FDA… | 2013 |
| * | K150018 | VS3-IR-MMS SystemSummary page 5…eration / Conditions of Use The VS3-IR System is made up of the following components: • VS3 3D Endoscope (K123467, K141002, K131434) • VS3-IR-MMS & ICG Kit (K150018) • VS3-IR-Endoscope & ICG Kit (not yet assigned). The following table summarizes FDA clearance history for the VS3-IR syst… | 2015 |
What descends from it? (34)
See all 342 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 21 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 10 of the 41 ancestors have a recall of any class.
- Of its descendants, K162882 (KARL STORZ Endoscopy-America, Inc., 2017) has gone furthest, with 32 descendants of its own.
- 2 other devices also cite its predicate K091515.
How does its category compare?
All OWN devicesOWN Confocal Optical Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 3D Endoscope Module of the VS3-IR System is intended for viewing internal surgical sites during general surgical procedures, for use in visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures. The MMS configuration of the Iridium…
Read the full statement (164 words)
The 3D Endoscope Module of the VS3-IR System is intended for viewing internal surgical sites during general surgical procedures, for use in visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures.
The MMS configuration of the Iridium Module of the VS3-IR System is intended for 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 in plastic, micro- and reconstructive surgical procedures.
The Endoscope configuration of the Iridium Module of the VS3-IR System is intended to provide real-time endoscopic visible and near infrared fluorescence imaging. Iridium Endoscope enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infrared imaging during minimally invasive surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152204: VS3-IR system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152204
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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