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FDA 510(k)

Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter

K-Number: K183599 · 2019-04-12

ApplicantInfraredx, Inc.
Decision Date2019-04-12
Product CodeOGZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter is a medical device manufactured by Infraredx, Inc.. It received FDA 510(k) clearance on 2019-04-12 under approval number K183599. The device is classified under product code OGZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter?

Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter is a medical device that received FDA 510(k) clearance on 2019-04-12. It is manufactured by Infraredx, Inc.. The 510(k) number is K183599.

When was Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter approved by the FDA?

Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter received FDA 510(k) clearance on 2019-04-12, under approval number K183599.

What company makes Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter?

Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter is manufactured by Infraredx, Inc..

What is the FDA product code for Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter?

The FDA product code for Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter is OGZ.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT02193425 Reliability of the Human Brain Connectome COMPLETED NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED

Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Infraredx, Inc.

K163345TVC Imaging System, TVC Catheter K213303Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42 K241576Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )

Related Devices (Code: OGZ)

K163345TVC Imaging System, TVC CatheterInfraredx, Inc. K241576Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )Infraredx, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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