510(k) · Cleared
ClearedMakoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infraredx, Inc. · OGZ Catheter, Intravascular, Plaque Morphology Evaluation
Cleared on Apr 12, 2019 after a 107-day review. The FDA summary names no predicate by number. 7 later devices descend from it.
- Decided
- Apr 12, 2019
- Review
- 107 days
- Class
- Class II
- Product code
- OGZ
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK183599 Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging…Infraredx, Inc. · 2019
- Descendant · cites it directly · 4 of its ownK221257 SpectraWAVE Imaging SystemSpectrawave, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK230691 HyperVue™ Imaging SystemSpectrawave, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK213303 Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro…Infraredx, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK253101 HyperVue™ Imaging System - IntegratedSpectrawave, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK251198 HyperVue™ SoftwareSpectrawave, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K221257SpectraWAVE Imaging SystemSpectrawave, Inc. · 2023 · cites it directly4descendants
- K230691HyperVue™ Imaging SystemSpectrawave, Inc. · 2023 · 2 generations on1descendant
- K213303Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging…Infraredx, Inc. · 2021 · cites it directly1descendant
- K253101HyperVue™ Imaging System - IntegratedSpectrawave, Inc. · 2025 · 2 generations on0descendants
- K251198HyperVue™ SoftwareSpectrawave, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K183599 | Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter | Infraredx, Inc. | 2019 | — |
| +1 | K221257 | SpectraWAVE Imaging System | Spectrawave, Inc. | 2023 | — |
| +2 | K230691 | HyperVue™ Imaging System | Spectrawave, Inc. | 2023 | — |
| +1 | K213303 | Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS… | Infraredx, Inc. | 2021 | — |
| +2 | K253101 | HyperVue™ Imaging System - Integrated | Spectrawave, Inc. | 2025 | — |
| +3 | K251198 | HyperVue™ Software | Spectrawave, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 4 | 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 OGZ? 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 OGZ device
- #1 K241576 Makoto Intravascular Imaging System™ (VC-MC10…score 9.2 · 2 generations · no Class I recall
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K221257 (Spectrawave, Inc., 2023) has gone furthest, with 4 descendants of its own.
How does its category compare?
All OGZ devicesOGZ Catheter, Intravascular, Plaque Morphology Evaluation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OGZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OGZ
Too few OGZ 510(k)s in any year since 2007 to give a median.
Recalls per year · OGZ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OGZ
2in 2025
MAUDE reports naming product code OGZ, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 1 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K183599 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183599: Makoto Intravascular Imaging System, Dualpro IVUS + NIRS 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/K183599
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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