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Neuro.Al Algorithm

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K200750

by Terarecon Inc.

Identifiers

510(k) Number
K200750 FDA 510(k)
FDA Product Code
LLZ 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 Neuro.Al Algorithm is a radiology software algorithm designed for automated analysis of neuroimaging data, specifically to assist in the detection and quantification of abnormalities in brain scans. It leverages advanced computational techniques to enhance diagnostic workflows by providing structured, interpretable outputs from medical imaging studies, such as MRI or CT scans.

This algorithm is supplied as a software-based solution for use in radiology departments, hospitals, or clinical research settings. It operates on standard imaging platforms and does not require physical sterilization or single-use disposal; however, its regulatory compliance includes FDA 510(k) clearance under Special Review (K200750) and adherence to the EU Medical Device Directive (MDD) and Medical Device Regulation (MDR). No specific MRI safety classification or sterility requirements are noted in the data, and its use is governed by the manufacturer’s software licensing terms.

Frequently asked questions

What types of brain scans can the Neuro.Al Algorithm analyze, and how does it assist radiologists in their workflow?

The Neuro.Al Algorithm is designed to analyze neuroimaging data from MRI and CT scans. It automates the detection and quantification of abnormalities in brain scans, providing structured and interpretable outputs. This helps radiologists streamline their workflow by reducing manual analysis time and improving consistency in identifying key findings.

Is the Neuro.Al Algorithm a single-use or reusable software solution, and what are its regulatory compliance requirements?

The Neuro.Al Algorithm is a reusable software solution, not requiring physical sterilization or single-use disposal. It is FDA 510(k) cleared under Special Review (K200750) and complies with the EU Medical Device Directive (MDD) and Medical Device Regulation (MDR). Its regulatory status is governed by these clearances and licensing terms set by the manufacturer.

How is the Neuro.Al Algorithm supplied, and does it require any special handling or storage conditions?

The Neuro.Al Algorithm is supplied as a software-based solution, meaning it is delivered digitally and integrated into existing radiology platforms. Since it is not a physical device, there are no specific sterility or storage requirements beyond standard IT infrastructure needs, such as secure servers and software licensing compliance.

What kind of support or training is typically provided for implementing the Neuro.Al Algorithm in a clinical setting?

While the provided data does not specify training details, as a software-based solution, the Neuro.Al Algorithm likely includes manufacturer-provided documentation, user guides, and possibly onboarding support to ensure proper integration and usage in radiology departments or clinical research settings. Contacting Terarecon Inc. directly would yield the most accurate information on available training resources.

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

European Union Active

MDR

United States Active

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Manufacturer

Manufacturer
Terarecon Inc.
FDA Applicant
Terarecon,Inc.

Sources (2)

  • FDA 510(k) K200750 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026