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Nucleus-X, Model 230X

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K081680

by NuMED, Inc.

Identifiers

510(k) Number
K081680 FDA 510(k)
FDA Product Code
DQY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1250 FDA 510(k)
Regulation Number
870.1250 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Nucleus-X, Model 230X is a cardiovascular device classified under the product code DQY, intended for use in diagnostic and interventional procedures related to the heart and vascular system. This device is designed to facilitate precise imaging and guidance during cardiac interventions, supporting procedures such as coronary angiography, percutaneous coronary intervention (PCI), and structural heart interventions.

Supplied sterile and intended for single-use, the Nucleus-X, Model 230X is regulated under the FDA’s 510(k) pathway with a Special clearance designation and is also compliant with the Medical Device Directive (MDD). It is manufactured by NuMED, Inc., and is intended for use in clinical settings where advanced imaging and real-time visualization are required. No additional regulatory status beyond the stated authorizations is implied.

Frequently asked questions

What types of heart procedures is the Nucleus-X, Model 230X specifically designed to support during imaging and guidance?

The Nucleus-X, Model 230X is designed to assist with diagnostic and interventional procedures such as coronary angiography, percutaneous coronary intervention (PCI), and structural heart interventions. Its primary purpose is to provide precise imaging and real-time visualization, which are critical for guiding these procedures in cardiovascular settings.

Is the Nucleus-X, Model 230X intended for reuse or is it meant to be used only once?

The Nucleus-X, Model 230X is supplied sterile and explicitly intended for single-use only. This ensures patient safety and maintains device performance for one procedure, aligning with best practices for medical imaging devices in clinical settings.

How is the Nucleus-X, Model 230X regulated, and what does its Special clearance designation mean?

The Nucleus-X, Model 230X is regulated under the FDA’s 510(k) pathway with a Special clearance designation, meaning it was determined to be substantially equivalent to a legally marketed predicate device after a more rigorous review process. It also complies with the Medical Device Directive (MDD) in international markets. This designation reflects its advanced role in cardiovascular imaging and interventional guidance.

What should I consider when storing the Nucleus-X, Model 230X before use?

Since the Nucleus-X, Model 230X is sterile and single-use, it must be stored in its original packaging to preserve sterility until immediately before use. Follow manufacturer guidelines for environmental conditions (e.g., temperature, humidity) if specified, though no storage instructions are provided in the data. Always check for expiration dates or tamper-evidence seals before opening.

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
NuMED, Inc.

Sources (2)

  • FDA 510(k) K081680 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026