510(k) · Cleared
ClearedGentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gentuity, LLC · NQQ System, Imaging, Optical Coherence Tomography (Oct)
Cleared on Feb 20, 2020 as substantially equivalent to K152120 (Lightlab Imaging, Inc., 2015) and 1 other predicate after a 127-day review. Its family tree reaches back 4 generations to 2013. 3 later devices descend from it.
- Decided
- Feb 20, 2020
- Review
- 127 days
- Class
- Class II
- Product code
- NQQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K123369 (2013). 6 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK123369 Ilumien OptisLightlab Imaging, Inc. · 2013
- 3 generations backK141453 Ilumien Optis, Dragonfly Optis Imaging CatheterLightlab Imaging, Inc. · 2014
- 2 generations backK150878 Ilumien OptisLightlab Imaging, Inc. · 2015
- 1 generation backK152120 OPTIS Mobile SystemLightlab Imaging, Inc. · 2015
- This deviceK192922 Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging CatheterGentuity, LLC · 2020
- Descendant · cites it directly · 2 of its ownK230620 Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging CatheterGentuity, LLC · 2023
- Descendant · 2 generations on · 1 of its ownK242239 HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10…Gentuity, LLC · 2024
- Descendant · 3 generations on · 0 of its ownK242966 Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging…Gentuity, LLC · 2025 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K230620Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging CatheterGentuity, LLC · 2023 · cites it directly2descendants
- K242239HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30…Gentuity, LLC · 2024 · 2 generations on1descendant
- K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K123369 | Ilumien Optis | Lightlab Imaging, Inc. | 2013 | — |
| −3 | K141453 | Ilumien Optis, Dragonfly Optis Imaging Catheter | Lightlab Imaging, Inc. | 2014 | — |
| −2 | K150878 | Ilumien Optis | Lightlab Imaging, Inc. | 2015 | — |
| −1 | K152120 | OPTIS Mobile System | Lightlab Imaging, Inc. | 2015 | — |
| 0 (this device) | K192922 | Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter | Gentuity, LLC | 2020 | — |
| +1 | K230620 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter | Gentuity, LLC | 2023 | — |
| +2 | K242239 | HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT… | Gentuity, LLC | 2024 | — |
| +3 | K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter | Gentuity, LLC | 2025 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 NQQ? 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 NQQ device
- #1 K251730 LIA Console (542-7)score 16.2 · 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? (2)
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 |
|---|---|---|---|
| * | K152120 | OPTIS Mobile SystemSummary page 4…Product Code: ORD Panel: Cardiovascular 3. PREDICATE DEVICES ILUMIEN OPTIS™ Mobile System, Lightlab Imaging, Inc., K152120 (Primary Predicate) Dragonfly™ OPTIS™ Imaging Catheter, Lightlab Imaging, Inc., K141453… | 2015 |
| * | K141453 | Ilumien Optis, Dragonfly Optis Imaging CatheterSummary page 4…r 3. PREDICATE DEVICES ILUMIEN OPTIS™ Mobile System, Lightlab Imaging, Inc., K152120 (Primary Predicate) Dragonfly™ OPTIS™ Imaging Catheter, Lightlab Imaging, Inc., K141453 Page 1 of 8… | 2014 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230620 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter | 2023 | 2 |
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 7 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K230620 (Gentuity, LLC, 2023) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K152120.
How does its category compare?
All NQQ devicesNQQ System, Imaging, Optical Coherence Tomography (Oct): FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · NQQ
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NQQ
146in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQQ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQQ
2in 2025
MAUDE reports naming product code NQQ, 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 | 3 | 82 | 1 | 0 |
| 2011 | 2 | — | 1 | 2 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 5 | 91 | 0 | 3 |
| 2016 | 5 | 91 | 0 | 2 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 3 | 84 | 0 | 6 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 3 | 86 | 0 | 6 |
| 2024 | 2 | — | 0 | 6 |
| 2025 | 8 | 146 | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter is intended for intravascular imaging and is indicated for use in coronary arteries in patients who are candidates for transluminal interventional procedures. The Vis-Rx Micro-Imaging Catheter is intended for use in vessels 1.3 to 6.0 mm in diameter. The Vis-Rx Micro-Imaging Catheter is not intended for use in a target vessel that has undergone a previous bypass procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192922 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192922: Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192922
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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