# K183599: Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Infraredx, Inc.
- Decided: Apr 12, 2019 after 107 days
- Product code: OGZ (Catheter, Intravascular, Plaque Morphology Evaluation)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K221257: SpectraWAVE Imaging System (2023), 4 descendants of its own
- K230691: HyperVue™ Imaging System (2023), 1 descendant of its own
- K213303: Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42 (2021), 1 descendant of its own
- K253101: HyperVue™ Imaging System - Integrated (2025), 0 descendants of its own
- K251198: HyperVue™ Software (2025), 0 descendants of its own

Source page: https://510kreport.com/device/K183599
Methodology: https://510kreport.com/methodology