510(k) · Cleared
ClearedMakoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )
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 Feb 26, 2025 as substantially equivalent to K213303 (Infraredx, Inc., 2021) after a 268-day review. Its family tree reaches back 2 generations to 2019.
- Decided
- Feb 26, 2025
- Review
- 268 days
- Class
- Class II
- Product code
- OGZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K183599 (2019). No later device cites it as a predicate yet.
- Root · 2 generations backK183599 Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging…Infraredx, Inc. · 2019
- 1 generation backK213303 Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro…Infraredx, Inc. · 2021
- This deviceK241576 Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™…Infraredx, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K183599 | Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter | Infraredx, Inc. | 2019 | — |
| −1 | K213303 | Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS… | Infraredx, Inc. | 2021 | — |
| 0 (this device) | K241576 | Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS… | Infraredx, Inc. | 2025 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K213303 | Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging…Summary page 5…t Code(s) OGZ, IYO, OBJ Legally Marketed Predicate Devices Predicate Number Predicate Trade Name Product Code K213303 TVC-E195-42, TVC-C195- OBJ, IYO, OGZ 42 & TVC-MC10/MC10i Device… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 3.2 years on median.
- None of the 2 ancestors has a recall.
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. 2025, 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 | — |
What is it indicated for?
1. The Makoto Intravascular Imaging SystemTM is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. c. The System is intended for the identification of patients and plaques at increased risk of major adverse cardiac…
Read the full statement (111 words)
1. The Makoto Intravascular Imaging SystemTM is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
a. The System is intended for the detection of lipid-core-containing plaques of interest.
b. The System is intended for the assessment of coronary artery lipid core burden.
c. The System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.
2. The System is intended for ultrasound examination of coronary and peripheral intravascular pathology.
a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary and peripheral interventional procedures. The System is not indicated for use in the cerebral vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241576: Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 ).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241576
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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