Infraredix NIR Imaging System Gen 1.0 Model MC-5
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K072932 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 device is a catheter, intravascular, plaque morphology evaluation system. It is designed for use in cardiovascular applications to evaluate plaque morphology using near-infrared imaging technology.
The system is supplied as a reusable imaging system and is intended for use in clinical settings. It has received FDA 510(k) clearance under product code OGZ and regulation number 870.1200, with clearance granted on April 25, 2008, based on substantial equivalence to a predicate device.
Frequently asked questions
What is the Infraredix NIR Imaging System used for?
The system is used for evaluating plaque morphology in cardiovascular applications using near-infrared imaging technology.
Is the Infraredix NIR Imaging System reusable?
Yes, the system is supplied as a reusable imaging system intended for use in clinical settings.
What type of clearance has the Infraredix NIR Imaging System received?
The system has received FDA 510(k) clearance under product code OGZ and regulation number 870.1200, based on substantial equivalence to a predicate device.
What model is the described Infraredix NIR Imaging System?
The described system is the Infraredix NIR Imaging System, Gen. 1.0, Model MC-5.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K072932 | Class II | Active |
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Manufacturer
- Manufacturer
- Infraredx, Inc.
Sources (1)
- FDA 510(k) K072932 24 fields · synced Sep 23, 2026