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InferRead Lung CT.AI

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K240554

by Infervision Medical Technology Co., Ltd.

Identifiers

510(k) Number
K240554 FDA 510(k)
FDA Product Code
OEB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The InferRead Lung CT.AI is a Computer-Aided Detection system for lung computed tomography (CT) imaging, designed to assist radiologists in identifying and analyzing pulmonary nodules and abnormalities within thoracic CT scans. Classified as a Class II medical device under FDA regulations, it leverages artificial intelligence to enhance diagnostic accuracy and efficiency in radiology workflows.

This software-based system is intended for use in radiology departments within hospital or clinic settings, operating on compatible CT imaging platforms. Supplied as a digital solution, it requires integration with existing CT systems and does not require sterilization or single-use disposal. The device is authorized under FDA 510(k) clearance and EU MDR compliance, with registration numbers and FEI numbers listed for regulatory tracking. No MRI safety considerations apply, as it is a software-based tool.

Frequently asked questions

What clinical setting is the InferRead Lung CT.AI intended for, and how does it integrate with existing systems?

The InferRead Lung CT.AI is designed for use in radiology departments within hospitals or clinics. As a software-based Computer-Aided Detection system, it requires integration with compatible CT imaging platforms already in use. There’s no need for physical installation or sterilization—it operates digitally to assist radiologists in analyzing thoracic CT scans for pulmonary nodules and abnormalities.

Is the InferRead Lung CT.AI a single-use or reusable device, and what are its storage requirements?

The InferRead Lung CT.AI is a software-based solution, so it is neither single-use nor reusable in the traditional sense. Since it doesn’t involve physical hardware or consumables, there are no specific storage requirements beyond maintaining the digital system’s compatibility with existing CT platforms and ensuring proper IT infrastructure support.

What regulatory pathways does the InferRead Lung CT.AI follow, and how can I verify its compliance?

The InferRead Lung CT.AI is authorized under FDA 510(k) clearance (K240554) and EU MDR compliance, with multiple registration numbers (e.g., 3001722928) listed for regulatory tracking. These details are publicly available through the FDA’s OpenFDA database or the manufacturer’s documentation, ensuring compliance with both U.S. and EU regulatory standards.

Does the InferRead Lung CT.AI require any special safety considerations, such as MRI compatibility?

No, the InferRead Lung CT.AI is a software-based tool and does not involve MRI technology. Since it operates independently of magnetic fields or imaging hardware, there are no MRI safety concerns—it is solely intended for use with CT systems in radiology workflows.

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

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Infervision Medical Technology Co., Ltd.

Sources (2)

  • FDA 510(k) K240554 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026