510(k) · Cleared
ClearedOPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · NQQ System, Imaging, Optical Coherence Tomography (Oct)
Cleared on Apr 24, 2026 as substantially equivalent to K210458 (Abbott Medical, 2021) after a 199-day review. Its family tree reaches back 4 generations to 2013. 1 of the 5 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 24, 2026
- Review
- 199 days
- Class
- Class II
- Product code
- NQQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K123369 (2013). No later device cites it as a predicate yet. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK123369 Ilumien OptisLightlab Imaging, Inc. · 2013
- 3 generations backK141769 Optis Integrated System, Dragonfly Optis Imaging CatheterLightlab Imaging, Inc. · 2014
- 2 generations backK192019 Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1Abbott Medical · 2019 · Recalled (Class I)
- 1 generation backK210458 OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging SystemAbbott Medical · 2021
- This deviceK253459 OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next…Abbott Medical · 2026
Class I recalls in this family
- K192019 Dragonfly OpStar™ Imaging Catheter, AptiVue™…2 generations back · 2019
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 | K141769 | Optis Integrated System, Dragonfly Optis Imaging Catheter | Lightlab Imaging, Inc. | 2014 | — |
| −2 | K192019 | Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 | Abbott Medical | 2019 | Class I |
| −1 | K210458 | OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System | Abbott Medical | 2021 | — |
| 0 (this device) | K253459 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging… | Abbott Medical | 2026 | — |
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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K210458 | OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging SystemSummary page 6…10 - Blood pressure computer Predicate OPTIS™ Mobile Next Imaging System, OPTIS™ Integrated Next Imaging Device System with Ultreon™ Software 1.0 (K210458) Device Description: The OPTIS™ Mobile Next is comprised of a cart-mounted personal computer, imaging engine, and power supply… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K192019Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1Abbott Medical · 2019 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 4 ancestors has a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K210458.
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. 2026, 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 Ultreon™ 3.0 Software is intended to be used only with compatible OPTIS™ Next Imaging Systems. The OPTIS™ Next Imaging Systems with a compatible Dragonfly™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ Imaging Catheter is not intended…
Read the full statement (437 words)
The Ultreon™ 3.0 Software is intended to be used only with compatible OPTIS™ Next Imaging Systems.
The OPTIS™ Next Imaging Systems with a compatible Dragonfly™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
The OPTIS™ Next Imaging Systems are intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment to determine if therapeutic intervention is indicated.
OPTIS Mobile Next System
The OPTIS™ Mobile Next with a compatible Dragonfly™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
The OPTIS™ Mobile Next is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment to determine if therapeutic intervention is indicated.
OPTIS Integrated Next System
The OPTIS™ Integrated Next with a compatible Dragonfly™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
The OPTIS™ Integrated Next is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment to determine if therapeutic intervention is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253459 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253459: OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253459
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026