510(k) · Cleared
ClearedHyperVue™ Imaging System
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 Jun 7, 2023 as substantially equivalent to K221257 (Spectrawave, Inc., 2023) after an 86-day review. Its family tree reaches back 4 generations to 2013. 1 of the 7 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jun 7, 2023
- Review
- 86 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. 1 later device descends from it, 1 citing it directly. 1 of the 7 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 deviceK230691 HyperVue™ Imaging SystemSpectrawave, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK251198 HyperVue™ SoftwareSpectrawave, Inc. · 2025
Class I recalls in this family
- K192019 Dragonfly OpStar™ Imaging Catheter, AptiVue™…2 generations back · 2019
Most influential descendants
Showing 1 of 1 · See all- K251198HyperVue™ SoftwareSpectrawave, Inc. · 2025 · cites it directly0descendants
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) | K230691 | HyperVue™ Imaging System | Spectrawave, Inc. | 2023 | — |
| +1 | K251198 | HyperVue™ Software | Spectrawave, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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 4…Product Code: NQQ, ORD, OGZ, IYO Classification: Class II 3. Predicate Device: • K221257, SpectraWAVE Imaging System and Catheter 4. Device Description: The HyperVue™ Imaging System is an i… | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251198 | HyperVue™ Software | 2025 | 0 |
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 10 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.
- Of its descendants, K251198 (Spectrawave, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 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. 2023, 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 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 is intended for the…
Read the full statement (124 words)
The HyperVue™ Imaging System 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 is intended for the detection of lipid core containing plaques of interest.
The NIRS capability of the HyperVue™ Imaging System is intended for the assessment of coronary artery lipid core burden.
The NIRS capability of the HyperVue™ Imaging System 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/K230691 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230691: HyperVue™ Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230691
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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