510(k) · Cleared
Recalled · Class II · 2026Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gentuity, LLC · DQO Catheter, Intravascular, Diagnostic
Cleared on Jan 31, 2025 as substantially equivalent to K242239 (Gentuity, LLC, 2024) after a 127-day review. Its family tree reaches back 7 generations to 2013. It has been recalled once.
- Decided
- Jan 31, 2025
- Review
- 127 days
- Class
- Class II
- Product code
- DQO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K123369 (2013). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK123369 Ilumien OptisLightlab Imaging, Inc. · 2013
- 6 generations backK141453 Ilumien Optis, Dragonfly Optis Imaging CatheterLightlab Imaging, Inc. · 2014
- 5 generations backK150878 Ilumien OptisLightlab Imaging, Inc. · 2015
- 4 generations backK152120 OPTIS Mobile SystemLightlab Imaging, Inc. · 2015
- 3 generations backK192922 Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging CatheterGentuity, LLC · 2020
- 2 generations backK230620 Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging CatheterGentuity, LLC · 2023
- 1 generation backK242239 HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10…Gentuity, LLC · 2024
- This deviceK242966 Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging…Gentuity, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K123369 | Ilumien Optis | Lightlab Imaging, Inc. | 2013 | — |
| −6 | K141453 | Ilumien Optis, Dragonfly Optis Imaging Catheter | Lightlab Imaging, Inc. | 2014 | — |
| −5 | K150878 | Ilumien Optis | Lightlab Imaging, Inc. | 2015 | — |
| −4 | K152120 | OPTIS Mobile System | Lightlab Imaging, Inc. | 2015 | — |
| −3 | K192922 | Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter | Gentuity, LLC | 2020 | — |
| −2 | K230620 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter | Gentuity, LLC | 2023 | — |
| −1 | K242239 | HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT… | Gentuity, LLC | 2024 | — |
| 0 (this device) | K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter | Gentuity, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 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 DQO? 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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 |
|---|---|---|---|
| * | K242239 | HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30…Summary page 6…Page 1 of 4 3. PREDICATE DEVICE Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter (K242239). 4. DESCRIPTION OF THE DEVICE The Gentuity® HF-OCT Imaging System provides images of the coronary arteries in patients… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 23, 2026 | Class II | Z-1823-2026 | Device Design | The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to ensure that users are fully… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 1.0 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The Gentuity® HF-OCT Imaging System with Vis-Rx® Prime 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 Prime Micro-Imaging Catheter is intended for use in vessels 1.3 to 6.0 mm in diameter. The Vis-Rx Prime Micro-Imaging Catheter is also intended for use prior to or following transluminal interventional procedures. The Vis-Rx Prime 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/K242966 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242966: Gentuity® HF-OCT Imaging System with Vis-Rx Prime® 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/K242966
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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