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CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4…

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K172455

by Volcano Corporation

Identifiers

510(k) Number
K172455 FDA 510(k)
FDA Product Code
IYO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1560 FDA 510(k)
Regulation Number
892.1560 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CORE M2 Vascular System is an intravascular imaging and guidance system designed for real-time visualization of coronary and peripheral vasculature. It integrates intravascular ultrasound (IVUS) imaging with advanced software tools to assist in the assessment and treatment of vascular diseases, including plaque characterization and stent optimization.

This system is supplied as a combination of hardware and software, including upgrade and installation kits for version 4.2. It is intended for use in clinical settings such as catheterization laboratories, with the software requiring compatible hardware for operation. The device is classified under the FDA’s Special 510(k) pathway and adheres to the Medical Device Directive (MDD), with no third-party involvement in its regulatory submission. The system is not single-use and must be maintained according to manufacturer guidelines.

Frequently asked questions

What clinical settings is the CORE M2 Vascular System intended for use in, and how does it assist in vascular treatments?

The CORE M2 Vascular System is designed specifically for use in catheterization laboratories, where real-time intravascular ultrasound (IVUS) imaging helps clinicians visualize coronary and peripheral blood vessels. It integrates advanced software tools to aid in assessing vascular diseases, such as identifying plaque characteristics and optimizing stent placement, improving precision during procedures like angioplasty or stenting.

Is the CORE M2 Vascular System single-use, or can it be reused after a procedure?

The CORE M2 Vascular System is not single-use and is intended for repeated use in clinical settings. However, it requires proper maintenance and adherence to the manufacturer’s guidelines to ensure continued performance and safety. Components like imaging catheters may still follow single-use protocols, but the core system itself is reusable.

What software versions are included in the upgrade and installation kits, and how do they integrate with the existing hardware?

The upgrade and installation kits provided are for CORE M2 Software v4.2, which is designed to work with compatible CORE M2 hardware. These kits allow clinicians to update their existing system to this version, ensuring access to enhanced imaging tools and software features for improved vascular assessment and treatment planning.

How was the regulatory pathway for the CORE M2 Vascular System determined, and which advisory committee reviewed it?

The CORE M2 Vascular System was cleared through the FDA’s Special 510(k) pathway, specifically under the Radiology (RA) advisory committee, with a decision code of SESE (Substantially Equivalent). This pathway was used due to the device’s classification under product code IYO, and the submission did not involve third-party involvement. The system also complies with the Medical Device Directive (MDD).

What type of maintenance or care is required for the CORE M2 Vascular System to ensure optimal performance?

Since the CORE M2 Vascular System is reusable, it must be maintained according to the manufacturer’s guidelines to ensure reliability and safety. This includes regular cleaning, calibration, and software updates (such as those provided in the v4.2 upgrade kit) to prevent degradation of imaging quality or system functionality. Proper storage and handling are also critical to avoid damage to the hardware components.

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 (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Volcano Corporation

Sources (2)

  • FDA 510(k) K172455 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026