510(k) · Cleared
ClearedHyperVue™ Imaging System - Integrated
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectrawave, Inc. · NQQ System, Imaging, Optical Coherence Tomography (Oct)
Cleared on Dec 15, 2025 as substantially equivalent to K221257 (Spectrawave, Inc., 2023) after an 82-day review. Its family tree reaches back 4 generations to 2013. 1 of the 6 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 15, 2025
- Review
- 82 days
- Class
- Class II
- Product code
- NQQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K123369 (2013). 5 ancestors in all. No later device cites it as a predicate yet. 1 of the 6 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 backK221257 SpectraWAVE Imaging SystemSpectrawave, Inc. · 2023
- This deviceK253101 HyperVue™ Imaging System - IntegratedSpectrawave, Inc. · 2025
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 | K221257 | SpectraWAVE Imaging System | Spectrawave, Inc. | 2023 | — |
| 0 (this device) | K253101 | HyperVue™ Imaging System - Integrated | Spectrawave, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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 |
|---|---|---|---|
| * | K221257 | SpectraWAVE Imaging SystemSummary page 5…21 CFR 892.1560 Number Product Code NQQ, IYO Classification Class II 3. Predicate Device: • Predicate Device: K221257, HyperVue Imaging System • Recall Status: The predicate device (K221257) has not been subject to a design-relat… | 2023 |
| † | K251198 | HyperVue™ Software | 2025 |
| † | K243016 | Starlight Imaging Catheter | 2025 |
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 12 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 5 ancestors has a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K221257.
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. 2025, 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 HyperVue ™ Imaging System - Integrated with compatible HyperVue ™ Software and Starlight ™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Starlight Imaging Catheter is intended for use in vessels 2.0 to 5.2 mm in diameter. The Starlight Imaging Catheter is not intended for use in a target vessel which has undergone a previous bypass…
Read the full statement (143 words)
The HyperVue ™ Imaging System - Integrated with compatible HyperVue ™ Software and Starlight ™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.
The Starlight Imaging Catheter is intended for use in vessels 2.0 to 5.2 mm in diameter.
The Starlight Imaging Catheter is not intended for use in a target vessel which has undergone a previous bypass procedure.
The NIRS capability of the HyperVue Imaging System - Integrated is intended for the detection of lipid core containing plaques of interest.
The NIRS capability of the HyperVue Imaging System - Integrated is intended for the assessment of coronary artery lipid core burden.
The NIRS capability of the HyperVue Imaging System - Integrated is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253101: HyperVue™ Imaging System - Integrated.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253101
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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