Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i) +2 more models
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K241576 FDA 510(k)
- FDA Product Code
- OGZ FDA 510(k)
- Models / Variants
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1200 FDA 510(k)
- Regulation Number
- 870.1200 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Makoto Intravascular Imaging System is a dual-modality intravascular imaging device designed for plaque morphology evaluation. It integrates Intravascular Ultrasound (IVUS) with Near-Infrared Spectroscopy (NIRS) to provide structural and chemical assessment of coronary and peripheral arteries, enabling identification of lipid core plaques (LCP). The system operates via a single catheter, delivering combined imaging and spectroscopic data for enhanced diagnostic accuracy.
The system is supplied as a reusable imaging console paired with single-use catheters, including the Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42) and Peripheral 014 Imaging Catheter (TVC-E195-42). Catheters are non-sterile and intended for single-use in controlled clinical environments. The device is classified as Class II under FDA regulations (21 CFR 870.1200) and holds a 510(k) clearance (K241576) for cardiovascular applications. Compatibility with MRI environments is not specified.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Makoto Intravascular Imaging System - Nipro, Makoto™ Imaging System / Dualpro™ IVUS+NIRS Imaging Catheter ..., Dualpro™ IVUS+NIRS Catheter | Nipro
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241576 | Class II | Active |
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Manufacturer
- Manufacturer
- Infraredx, Inc.
Sources (1)
- FDA 510(k) K241576 24 fields · synced Sep 20, 2026