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Lipiscan IVUS Imaging System Model NIRS-MC7-70

FDA 510(k)

Class II (US FDA 510(k))

510(k) K093993

by Infraredx, Inc.

Identifiers

510(k) Number
K093993 FDA 510(k)
FDA Product Code
OGZ FDA 510(k)

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 Lipiscan IVUS Imaging System Model NIRS-MC7-70 is an intravascular catheter designed for plaque morphology evaluation. It integrates near‑infrared spectroscopy (NIRS) with intravascular ultrasound (IVUS) to provide co‑registered grayscale ultrasound and lipid‑core plaque detection, allowing visualization and characterization of coronary lesions during angiography.

The system is advanced over an existing guidewire and can be introduced via femoral or radial arterial access during coronary angiography. It is classified as a Class II device and received FDA 510(k) clearance (decision date 2010‑06‑30, decision description “Substantially Equivalent”). The device is supplied as a single catheter unit; sterility, reuse, and MRI safety are not specified in the available data.

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: Lipiscan Ivus Imaging System Model Nirs-mc7-70, PDF lipiscan_ivus_factsheet__final.indd - AVIDAL, Lipiscan Ivus Imaging System Model Nirs-mc7-70, TVC IMAGING SYSTEM MODEL NIRS-MC7-70 - Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Infraredx, Inc.

Sources (1)

  • FDA 510(k) K093993 24 fields · synced Sep 23, 2026